(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.
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Section 11 510(k) Device Summary
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Submitter
Canterbury Scientific Limited 21 Wroxton Terrace Christchurch New Zealand Phone and FAX (+643) 355 5598
Contact Person Maurice Owen, Laboratory Manager, Canterbury Scientific Ltd.
Date of Preparation 03 May 2002
Hemoglobin A1c Control Device Name
Class II, LCP Classification "
Equivalent Device
Lyphochek Diabetes Control Level 1 & 2, Bio-Rad Laboratories. (510(k) = K831478)
Description of Device 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.
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Intended Use of Device
The Hemoglobin A1c Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. The two levels of controls allow performance monitoring within the clinically important range.
The measurement of HbA1c is especially useful in insulindependent diabetic patients where blood glucose levels fluctuate widely and where the instantaneous blood glucose does not reflect the averaged situation. The formation of HbA1c occurs slowly (about 0.05%/day) and continuously during the 120-day lifetime of the red cell. Hence the measurement of HbA1c is useful to physicians as a long-term integral of blood glucose concentration and thus as a measure of the degree of control or self-management by the diabetic patient. The normal range for HbA1c is 4% - 6% of total hemoglobin. Each percentage point increase in HbA1c level corresponds to an increase in average blood glucose level of about 30 mg/dL or 1.7mmol/L. As a general rule HbA1c levels above 10% represent poor diabetic control, whereas values of about 7% are indicative of good control.
The controls are for in vitro diagnostic use only and should not be used past the expiry date. Thev are not intended to be used as standards or calibrants.
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| Hemoglobin A1c ControlNew Device | Lyophochek DiabetesControl, Levels 1 and 2Bio-Rad Laboratories | |
|---|---|---|
| 510(k) Number | K831478 | |
| Type of Product | Quality Control Product | Quality Control Product |
| Description | Lyophilized Hemoglobin Control | Lyophilized Hemoglobin Control |
| Type of Vial and Cap | 3.5mL clear borosilicate glassvial with plastic screw cap andphenolic moisture barrier liner. | 10 mL amber glass serum vialwith butyl rubber insert andaluminum crimp top. |
| Intended Use | As a quality control lysate tomonitor the precision oflaboratory procedures formeasurement of HbA1c | As a quality control lysate tomonitor the precision oflaboratory procedures formeasurement of HbA1c andHbA1 |
| Contents of Vials | Human hemoglobins (HbA,HbA1c, HbF, HbA2),Cryopreservative, broadspectrum antibiotic, stabilizers. | Human hemoglobins (HbA,HbA1c, HbF, HbA2, HbS),preservatives, stabilizers |
| Serology Testing of HumanSource Material | Non-reactive for:Hepatitis B Surface Antigen●Antibody to Hepatitis C●Antibody to HIV-1 & HIV-2●Syphilis (TPHA & RPR) | Non-reactive for:● Hepatitis B Surface Antigen● Antibody to Hepatitis C● Antibody to HIV-1 & HIV-2Syphilis testing status not known |
| Number of Levels | 2 (Normal and Abnormal) | 2 (Level 1 [normal] and level 2[Abnormal]) |
| Storage | 2°-8°C | 2°-8°C |
| Stability of Lyophilized Product | 3 years at 2° - 8°C | ? 3 years at 2° - 8°C |
| Stability Reconstituted Control | 13 weeks at 2°-8°C | 7 days at 2° - 8°C |
| Reconstitution Volume | 0.25 - 0.5mL | 0.5mL |
| Moisture (Loss on Drying) | Less than 3% | Not known, but likely to be lessthan 3% |
| Target Value and acceptablerange for Level 1 Composition(For the Bio-Rad product the targetfigures are not known, so a typicalrange (lot 33591) is given) | 5.0% (4.5% - 6.0%) | Mean 5.1% - 5.6% (range 4.7%- 6.0%) for HPLC methods givenin information sheet |
| Target Value and acceptablerange for Level 2 Composition(For the Bio-Rad product the targetfigures are not known, so a typicalrange (lot 33592) is given) | 10.5% (10.0% - 13.0%) | Mean 9.8% - 10.3% (range9.0% - 11.3%) for HPLCmethods given in informationsheet |
| Methods Suitable for Controls | HPLC, lateximmunoagglutination inhibition | HPLC, lateximmunoagglutination inhibition |
Comparison of Technological Characteristics with Predicate Device
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head facing a different direction. The eagle's body is represented by flowing lines.
Food and Drug Administration 2098 Garther Road Rockville MD 20850
JUN 1 4 2002
Maurice Owen. Ph.D. Laboratory Manager Canterbury Scientific Limited 21 Wroxton Terrace Christchurch 8001 New Zealand
Re: K021484
Trade/Device Name: Hemoglobin A1c Control Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: May 30, 2002 Received: June 3, 2002
Dear Dr. Owen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 10 Statement of Indications for Use
- 10.1 Device Name
Hemoglobin A1c Control
10.2 Indications for Use
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.
Josephine Bautier
linical Laboratory Devices 510(k) Number
§ 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).