Afinion a1c error codes

Author: btvi

August undefined, 2024

WebTroubleshooting –Most Frequently Observed Error Codes (See SOP for Full List) Error Code Description Troubleshooting 103, 104 Hemoglobin concentration is below or above the … WebAfinion™ HbA1c Control contains liquid preparations of Stabilized Porcine Whole Blood (Control CI) and Human Whole Blood (Control CII). Designed for use with the Afinion™ …

Afinion HbA1c Quick Guide - YUMPU

WebHbA1c is nonenzymatically synthesized in two steps: The glucose aldehyde group and the free amino group on the valine in the N-terminus of the hemoglobin beta chain react to form the Schiff base, aldimine (also known as labile HbA1c or LA1c). A stable ketoamine form of the hemoglobin complex (SA1c) is then produced by conan o\u0027brien matthew broderick wooden

HbA1c - Stat Technologies

WebJul 22, 2016 · The Alere Afinion™ HbA1c Dx test is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human … WebNov 7, 2024 · The following codes do not, in and of themselves, indicate uncontrolled diabetes and must be used in conjunction with a Group 1 code that indicates a current state of uncontrolled diabetes (hyperglycemia) Secondary (Dual) Diagnoses Group 2 Codes Group 3 (30 Codes) Group 3 Paragraph WebThe precision of the Afinion™ HbA1c Dx was evaluated based on CLSI guideline EP05-A3. Four levels of HbA1c in anticoagulated venous whole blood patient samples at the following targeted HbA1c values - 5, 6.5, 8 and 12 %HbA1c - were utilized in the study. Three test cartridge lots were included in the study. Two replicates of venous whole blood conan o\u0027 brien needs a friend

Quick Reference Guide - Stat Technologies

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …

WebInformation Codes and Troubleshooting When an information code appears Information codes that might appear during use of the Afinion 2 Analyzer refer to specific … WebMar 28, 2024 · A1cnow Error Codes Mar 28, 2024 Evaluation Of An Over-the-counter Glycated Hemoglobin (a1c) Test Kit Glycated hemoglobin (A1C) monitoring is an integral … conan o\u0027brien looking at clivageWebSep 29, 2024 · Repeat the test with a new sample afinion a1c error codes results for websites listing. Repeat the test using a sample from a new control lot. Alere afinion™ hba1c is waived under the clinical laboratory improvement amendment information codes caused by sample or test cartridge failure. conan o\u0027brien kevin hart ice cube lyft

"WebAlere Afinion™ AS100: Manufacturer: Abbott Rapid Dx North America LLC: Country of Origin: Unknown: Application: Point-of-Care Analyzer: CLIA Classification: CLIA Waived for HbA1c / CLIA Moderate Complexity for ACR: Dimensions: 12-2/3 X 6-2/3 X 6-2/3 Inch: For Use With: For Afinion™ Test Cassettes Only: Power Source: AC / DC Power Adapter ... " - Afinion a1c error codes

Afinion a1c error codes

WebThe Afinion™ HbA1c assay is a test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used to monitor metabolic control in patients with diabetes. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies. WebMay 20, 2024 · The probable explanation was that the detection systems causing the error codes were too sensitive. Regardless of cause, the frequency of error codes was assessed as too high. Conclusion Afinion was easy to handle. The precision of Afinion was good and fulfilled the quality goal.

Did you know?

WebAﬁnion HbA1c is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human capillary and venous whole blood. … WebAbout 50% of the A1C result is from the past 30 days; about 25% is from the past 30-60 days and about 25% is from the past 60-120 days.1 Depending on the test methodology used, laboratory methods show that the reference range of the A1C test is approximately 4.0-6.5% A1C, and 6% to 9% in people with well to moderately controlled 1diabetes.

http://nwprimarycare.com/Staff%20Training%20Info/Afinion%20HbA1c%20User%20Manual.pdf WebThe probable explanation was that the detection systems causing the error codes were too sensitive. Regardless of cause, the frequency of error codes was assessed as too high. Conclusion Afinion was easy to handle. The precision of …

WebAfinion AS100 Analyzer (k050574, k110056) and Afinion HbA1c Controls (k050574). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Diagnostics Cobas C501 Tina-Quant HbA1c cDx Gen 3 assay 2. Predicate 510(k) number(s): k121610 3. Comparison with predicate: Similarities Item Candidate Device Afinion HbA1c Dx … WebAlere Afinion™ AS100: Manufacturer: Abbott Rapid Dx North America LLC: Country of Origin: Unknown: Application: Point-of-Care Analyzer: CLIA Classification: CLIA Waived …

WebA1CNow Troubleshooting Troubleshooting See the table below for a description of A1CNow Self Check test system operating and error codes. (OR = Out of Range; QC = Quality …

WebDevice Performance FDA is still evaluating the performance characteristics of the . Afinion HbA1c Dx system (e.g., accuracy, precision) Today’s discussion focus is on point -of-care (POC) economy is one powerful motive for campingWebDec 7, 2015 · Afinion HbA1c Control• Store the controls refrigerated (2-8°C). Opened controls are stable for 60 days.•. Allow the control to reach a temperature of 15-25°C before use, which takesapproximately 30 minutes.•. Mix the control thoroughly by shaking the vial for 30 seconds before use.•. The measured value should be within the acceptable ... conan o\\u0027brien kevin hart ice cubeWebThe Afinion™ 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care. With the Afinion™ System, there’s no need to send test results to the lab or spend time tracking them down. ... Code: Afinion™ 2 Analyzer. 1116679 (Worldwide) ... B5592 (EMEA ONLY) Related Products. Afinion ... conan o\u0027brien matthew broderick wooden puppetWebhemoglobin a1c test system: 510(k) Number ... Device Name: Afinion HbA1c Dx: Applicant: Alere Technologies AS: Kjelsaasveien 161: Oslo, NO NO-0884 Applicant Contact: Monica Vallestad: ... Annie Wright: Regulation Number: 862.1373: Classification Product Code: PDJ : Date Received: 02/02/2024: Decision Date: 05/07/2024: Decision: Substantially ... conan o\u0027brien needs a friendWebThe 3-minute Alere Afinion HbA1c testing fits perfectly within the workflow: “Point-of-care HbA1c testing represents an opportunity ... PRODUCT NAME PRODUCT CODE ALERE … economy is lowWebInformation codes caused by test-specific limitations hidden 103 Cause Hemoglobin too low Action to Take Consult the Affinion HbA1c Package Insert 104 Cause Hemoglobin too … conan o\u0027brien dartmouth speech transcriptPlease consult the Afinion™ Analyzer User Manual for the operation of the analyzer and general handling of the test cartridge. Technical Support The manufacturer provides a toll-free line for technical support. Call 1-866-216-9505 (available for use only in the United States of America) 1116974 1117104 Rev. A … See more Intended use Afinion HbA1c is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human capillary and venous … See more Refrigerated storage 2-8°C (36-46°F) 1. The Afinion HbA1c Test Cartridges are stable until the expiration date only when stored refrigerated. The expiration date is stated on each foil … See more Consult the Afinion HbA1c Quick Guide for detailed instructions on how to collect and analyze a patient sample or control. Test procedure overview … See more The following sample materials can be used with the Afinion HbA1c test: 1. Capillary blood sample (from a finger prick). 2. Venous … See more conan o\\u0027brien needs a friend earwolf