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510(k) Data Aggregation
(137 days)
Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of -care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.
Afinion™ HbA Ic is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS100 Analyzer System. Quality control using the Afinion™ HbA 1c Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
Instrument read, single usc in-vitro test for quantitative determination of glycated hemoglobin in human whole blood.
Afinion™ AS100 Analyzer utilizes a digital camera and Light Emitting Diodes to perform two kinds of measurements; reflection mcasurement (amount of light rcflected from a membrane) and transmission measurement (amount of light propagating through a liquid). The analyzer is self-calibrated and no calibration by user is needed.
This looks like a 510(k) summary for a medical device called Afinion™ HbA1c, Afinion™ HbA1c Control, and Afinion™ AS100 Analyzer. I will extract the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally inferred from the "acceptable agreement" statements and specific thresholds mentioned for CV, linearity, and interference.
| Study Type | Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Method Comparison (Internal) | Acceptable agreement (implied by predicate equivalence) | Bias: -0.3 % HbA1c; 95% Limit of Agreement: -1.0 to 0.4 % HbA1c (vs. Bayer DCA 2000®) |
| Method Comparison (External) | Acceptable agreement (implied by predicate equivalence) | Slope: 0.91; y-intercept: 0.2 % HbA1c; r²: 0.96 (vs. Bayer DCA 2000®) |
| Method Comparison (vs. ERL Ref Method) | Excellent agreement (implied by predicate equivalence) | Bias: 0.0 % HbA1c; 95% Limit of Agreement: -0.3 to 0.3 % HbA1c (vs. Primus CLC385) |
| Capillary vs. Venous Blood | Excellent agreement | Bias: 0.0 %; 95% Limit of Agreement: -3.5 to 3.6 %; Slope: 0.99; y-intercept: 0.1 % HbA1c; r²: 0.99 |
| Precision (Internal) | Within-run CV < 1.0%; Total CV ≤ 1.4% (for individual analytes) | Within-run CV: <1.0%; Total CV: ≤1.4% for both blood samples and controls |
| Precision (Internal, Multi-Analyzer) | CV ≤ 5% | CV: 2.1% and 2.8% on two blood samples |
| Precision (External) | Total CV < 2.5% (for EDTA samples) | Total CV: < 2.5% for all three EDTA samples (A, B, C) |
| Dilution Linearity | Meet all criteria for linearity (implied r² close to 1, slope close to 1, y-intercept close to 0) | Correlation coefficient r² = 1.00; Slope = 1.01; Y-intercept = 0.07 % HbA1c (analytical range 4-18% HbA1c) |
| Hb-Variant Interference | No interference (implied, by meeting ERL certification) | HbAC, HbAE, HbAD, HbAJ, HbAS, HbF, and carbamylated Hb do not interfere |
| Preglycated Hb Interference | ≤ 5% interference | ≤ 5% interference with the % HbA1c results for samples with up to 22% preglycated hemoglobin |
| Endogenous Interfering Substances | ≤ 2% interference | Bilirubin (0.2 mg/mL), glucose (5.0 mg/mL), lipids (triglycerides; 15.7 mmol/L and cholesterol; 9.1 mmol/L) or fructosamine (680 umol/L) gave ≤ 2% interference |
| Exogenous Interfering Substances (Drugs) | ≤ 3% interference | Glyburide (3.9 umol/L), metformin (310 umol/L), acetaminophen (1.7 mmol/L), ibuprofen (1.8 mmol/L), acetylsalicylic acid (3.3 mmol/L) and salicylic acid (4.3 mmol/L) gave ≤ 3% interference |
| Hemolysis Interference | Negligible interference (<4%) for low degree; Error code for high degree | For low degree of hemolysis (below 6%), <4% interference observed. For above 6% hemolysis, information code 204 (Hemolysed blood sample) displayed, and no result occurred. |
| Anticoagulant Comparison | No difference in results; Recoveries 98-103%; Average recoveries 100-101% compared to EDTA | No difference between capillary and venous blood with different anticoagulants (EDTA, Heparin, Na-citrate, NaF). Recoveries between 98-103% for each donor and anticoagulant; average recoveries 100-101% compared to EDTA. |
| Fail-safe System | Functioning satisfactorily (device aborts assay and ejects cartridge on error) | 51 error messages observed during external study, all leading to assay abortion and cartridge ejection, with no result displayed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Method Comparison (Internal): 40 venous EDTA blood samples. Provenance: Not explicitly stated, but "analyzed internally" suggests within the manufacturer's lab. Retrospective or prospective is not specified.
- Method Comparison (External): 75 venous EDTA blood samples. Provenance: Three external study sites. Retrospective or prospective is not specified.
- Method Comparison (vs. European Reference Laboratory): 39 venous EDTA blood samples. Provenance: European Reference Laboratory for glycohemoglobin (ERL). Retrospective or prospective is not specified.
- Capillary vs. Venous Blood: 74 donors. Provenance: "analyzed externally." Retrospective or prospective is not specified.
- Precision (Internal): Two levels of blood samples and two controls. Numbers of replicates/runs not explicitly given for total samples, but for multi-analyzer test, two blood samples were used.
- Precision (External): Three EDTA blood samples (A, B, C). Provenance: Three external study sites.
- Dilution Linearity: One high HbA1c sample mixed with a low HbA sample to create seven intermediate concentrations.
- Hb-Variant Interference: Not explicitly specified, but "studies performed according to the ERL Manufacturer Check Up Certification procedure."
- Preglycated Hb Interference: Not explicitly specified, but "Blood samples with up to 22 % preglycated hemoglobin."
- Endogenous Interfering Substances: EDTA blood samples (number not specified).
- Exogenous Interfering Substances (Drugs): EDTA blood samples (number not specified).
- Hemolysis Interference: Samples with varying degrees of hemolysis.
- Anticoagulant Comparison: 10 donors.
General Data Provenance: The studies were conducted by Axis-Shield PoC AS (Norway) and external study sites, including the European Reference Laboratory (ERL). The data is likely a mix of internally and externally generated data from Europe/US. The text does not explicitly state if the studies were retrospective or prospective, but the phrasing suggests prospective testing for most assays.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish a ground truth in the sense of a subjective expert reading/diagnosis. Instead, the ground truth for this device (an HbA1c assay) is established by:
- Reference Methods: The predicate device (Bayer DCA 2000® Hemoglobin A1c assay) and the ERL reference method (Primus CLC385), which are themselves considered established and validated laboratory methods for HbA1c. These methods have inherent analytical capabilities, not dependent on expert interpretation for individual results.
- IFCC Traceability: The device's results are traceable to the International Federation of Clinical Chemistry (IFCC) Reference Method and reported at DCCT-level via the NGSP Master Equation. This standardization provides the "true" value.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. This is an in-vitro diagnostic device that provides quantitative numerical results, not subjective interpretations requiring human adjudication. The "ground truth" is established by comparison to other analytical methods or reference standards, not by consensus among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an automated assay for quantitative determination of HbA1c, not an AI system designed to assist human readers in interpreting images or data. There is no human reading component or AI assistance involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, this entire submission describes standalone performance. The Afinion™ AS100 Analyzer System is a fully automated assay system ("algorithm only") that quantifies HbA1c in human whole blood. The performance studies evaluate the device's ability to accurately and precisely measure HbA1c without human intervention in the result generation, beyond sample loading and initiation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is primarily comparison to established reference methods and predicate devices.
- Predicate Device: Bayer DCA 2000® Hemoglobin A1c assay (K951361).
- Reference Method: Primus CLC385 as used by the European Reference Laboratory for glycohemoglobin (ERL).
- International Standardization: Traceability to the IFCC Reference Method and reporting at DCCT-level via the NGSP Master Equation.
- Analytical Verification: For aspects like precision, linearity, and interference, the ground truth is against defined analytical standards and expected behaviors of known samples.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI. This is a traditional IVD device. The development and calibration of such a device would involve numerous samples, but it's not a "training set" in the AI sense. The text mentions the analyzer is "self-calibrated and no calibration by user is needed," implying built-in calibration mechanisms developed during the device's engineering, not through an explicit "training set" as with AI algorithms.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. The device's internal calibration and algorithms were likely established through engineering and analytical validation using a wide range of known HbA1c concentrations and blood samples, traceable to international standards during its development phase.
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