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.
Device Story
Hemoglobin A1c Control is a lyophilized quality control material derived from normal adult human blood; includes normal and abnormal levels. Abnormal level prepared via controlled glycation of normal hemolysate. Used in clinical laboratories to monitor precision of HbA1c quantitation methods (e.g., HPLC, latex immunoagglutination inhibition). Reconstituted with distilled water or biocide-containing solution; stored at 2-8°C. Provides objective assessment of laboratory method performance; assists in verifying accuracy of long-term blood glucose monitoring for diabetic patients. Not intended for patient self-use or as a calibrant.
Clinical Evidence
No clinical data. Bench testing only. Comparison of target values and acceptable ranges provided for normal and abnormal levels against predicate device. Stability testing demonstrated 13-week reconstituted stability at 2-8°C.
Technological Characteristics
Lyophilized human hemoglobin (HbA, HbA1c, HbF, HbA2) in 3.5mL clear borosilicate glass vials with plastic screw caps. Contains cryopreservative, broad-spectrum antibiotic, and stabilizers. Reconstitution volume 0.25-0.5mL. Compatible with HPLC and latex immunoagglutination inhibition methods. Storage 2-8°C.
Indications for Use
Indicated for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation in clinical settings. Not for use as a standard or calibrant.
Regulatory Classification
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.
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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 Control<br>New Device | Lyophochek Diabetes<br>Control, Levels 1 and 2<br>Bio-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 glass<br>vial with plastic screw cap and<br>phenolic moisture barrier liner. | 10 mL amber glass serum vial<br>with butyl rubber insert and<br>aluminum crimp top. |
| Intended Use | As a quality control lysate to<br>monitor the precision of<br>laboratory procedures for<br>measurement of HbA1c | As a quality control lysate to<br>monitor the precision of<br>laboratory procedures for<br>measurement of HbA1c and<br>HbA1 |
| Contents of Vials | Human hemoglobins (HbA,<br>HbA1c, HbF, HbA2),<br>Cryopreservative, broad<br>spectrum antibiotic, stabilizers. | Human hemoglobins (HbA,<br>HbA1c, HbF, HbA2, HbS),<br>preservatives, stabilizers |
| Serology Testing of Human<br>Source Material | Non-reactive for:<br>Hepatitis B Surface Antigen<br>●<br>Antibody to Hepatitis C<br>●<br>Antibody to HIV-1 & HIV-2<br>●<br>Syphilis (TPHA & RPR) | Non-reactive for:<br>● Hepatitis B Surface Antigen<br>● Antibody to Hepatitis C<br>● Antibody to HIV-1 & HIV-2<br>Syphilis testing status not known |
| Number of Levels | 2 (Normal and Abnormal) | 2 (Level 1 [normal] and level 2<br>[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 less<br>than 3% |
| Target Value and acceptable<br>range for Level 1 Composition<br>(For the Bio-Rad product the target<br>figures are not known, so a typical<br>range (lot 33591) is given) | 5.0% (4.5% - 6.0%) | Mean 5.1% - 5.6% (range 4.7%<br>- 6.0%) for HPLC methods given<br>in information sheet |
| Target Value and acceptable<br>range for Level 2 Composition<br>(For the Bio-Rad product the target<br>figures are not known, so a typical<br>range (lot 33592) is given) | 10.5% (10.0% - 13.0%) | Mean 9.8% - 10.3% (range<br>9.0% - 11.3%) for HPLC<br>methods given in information<br>sheet |
| Methods Suitable for Controls | HPLC, latex<br>immunoagglutination inhibition | HPLC, latex<br>immunoagglutination 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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Page 2 -
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
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