(37 days)
The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. They are prepared from normal adult human blood The source blood is tested and found to be non-reactive for Hepatitis B surface antigen, Hepatitis C antibody, antibodies against human immunodeficiency virus (HIV) types 1 & 2, and Syphilis (RPR and TPHA). The Abnormal Level Control is prepared by controlled glycation of normal non-diabetic hemolysate. The controls are reconstituted with distilled water or a reconstitution solution comprising the biocide sodium azide (0.09%). The reconstitution volume is between 0.25 mL and 0.5 mL. The controls reconstitute in 15 minutes with occasional swirling, and are stored at 2° - 8°C.
This is a 510(k) summary for a Hemoglobin A1c Control device, which is a quality control material used to monitor the precision of laboratory testing procedures for HbA1c quantitation. It is not an AI/ML device for diagnosis or treatment. The provided text refers to a traditional in vitro diagnostic device. Therefore, many of the typical questions for AI/ML device studies (like expert consensus, adjudication methods, multi-reader multi-case studies, and AI effect size) are not applicable to this type of submission.
The "study" here is a comparison of technological characteristics and performance between the new device and a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic accuracy.
Here's the breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for a quality control device typically revolve around its stability, composition, and its ability to perform similarly to predicate devices across different measurement methods. The reported performance is primarily a comparison against a predicate device.
| Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (New Device) |
|---|---|
| Intended Use | As a quality control lysate to monitor the precision of laboratory procedures for measurement of HbA1c |
| Description | Lyophilized Hemoglobin Control |
| Type of Vial and Cap | 3.5mL clear borosilicate glass vial with plastic screw cap and phenolic moisture barrier liner. |
| Contents of Vials | Human hemoglobins (HbA, HbA1c, HbF, HbA2), Cryopreservative, broad spectrum antibiotic, stabilizers. |
| Serology Testing (Human Source Material) | Non-reactive for: Hepatitis B Surface Antigen, Antibody to Hepatitis C, Antibody to HIV-1 & HIV-2, Syphilis (TPHA & RPR) |
| Number of Levels | 2 (Normal and Abnormal) |
| Storage | 2°-8°C |
| Stability of Lyophilized Product | 3 years at 2° - 8°C |
| Stability Reconstituted Control | 13 weeks at 2°-8°C |
| Reconstitution Volume | 0.25 - 0.5mL |
| Moisture (Loss on Drying) | Less than 3% |
| Target Value & Acceptable Range (Level 1) | 5.0% (4.5% - 6.0%) |
| Target Value & Acceptable Range (Level 2) | 10.5% (10.0% - 13.0%) |
| Suitable Methods | HPLC, latex immunoagglutination inhibition |
The "study" demonstrating these meet the criteria is presented as a "Comparison of Technological Characteristics with Predicate Device" shown in the table. The primary evidence for acceptance is the demonstration of substantial equivalence to the predicate device (Lyphochek Diabetes Control Level 1 & 2, Bio-Rad Laboratories, K831478) based on these characteristics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The comparison is based on the characteristics of the manufactured control materials themselves. For quality control materials, "sample size" might refer to the number of lots manufactured and tested or the replicates of aliquots tested to determine stability and target values. This information is not detailed in the provided summary.
- Data Provenance: Not applicable in the sense of patient data. The product is a manufactured in vitro diagnostic control. The source material is normal adult human blood, tested for pathogens. The device is manufactured by Canterbury Scientific Limited in Christchurch, New Zealand.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of images or clinical data to establish a "ground truth" in that sense. The "ground truth" for the control material is its chemical composition and its measured HbA1c values, which are determined by established laboratory methods and validated against known standards, not by expert consensus in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical interpretation requiring adjudication.
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 is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this device (a quality control material) is its chemical composition, stability, and the target HbA1c values, established through:
- Analytical Testing: Rigorous laboratory testing using recognized methods (e.g., HPLC, latex immunoagglutination inhibition) to determine the precise HbA1c percentage, other hemoglobin fractions, and stability over time.
- Reference Standards: Calibration against international or national reference standards for HbA1c measurement.
- Manufacturing Specifications: Adherence to defined manufacturing processes to ensure consistent product attributes.
- Predicate Device Comparison: Used as a benchmark for performance characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).