LIQUID STABLE HBA1C CONTROL

K043070 · Canterbury Scientific , Ltd. · JJX · Dec 9, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043070
• Device Name: LIQUID STABLE HBA1C CONTROL
• Applicant: Canterbury Scientific , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Liquid Stable HbA1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based assays and Boronate Affinity based assays.

Device Story

Liquid Stable HbA1c Control is a bi-level, ready-to-use quality control material derived from human red cells; used in clinical laboratories to monitor precision and bias of HbA1c testing procedures. Compatible with ion exchange HPLC, Immunoassay, and Boronate Affinity assays (e.g., Bayer DCA 2000, Bio-Rad Variant II, Roche Hitachi 917, Primus CLC 385). Controls provide objective assessment of method performance within clinical range. Human source material tested negative for HIV, HBV, HCV, and Syphilis. Healthcare providers use control results to verify assay accuracy and reliability as part of standard laboratory practice.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed open vial stability of 30 days and closed vial stability of 18 months at 2-8°C. Expected ranges for normal and abnormal levels were established via duplicate testing across three methodologies.

Technological Characteristics

Bi-level liquid control; matrix consists of human hemoglobins, broad-spectrum antibiotic, and stabilizers. Ready-to-use. Storage at 2-8°C. Compatible with ion exchange HPLC, Immunoassay, and Boronate Affinity platforms.

Indications for Use

Indicated for use as a quality control material to monitor the precision and bias of laboratory HbA1c quantitation procedures. Intended for in vitro diagnostic use by laboratory professionals to monitor performance within the clinical range. No specific patient population or contraindications listed.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Quantimetrix Corporation, GlycoHemosure HbA1c Control (k032791)

Submission Summary (Full Text)

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# Section 11 510(k) Device Summary

Image /page/0/Picture/2 description: The image shows the logo for Canterbury Scientific Ltd. The logo features the word "Canterbury" stacked on top of the word "Scientific", with "Ltd" in a smaller font size to the right of "Scientific". To the left of the text is a stylized graphic that resembles a laboratory flask or beaker.

14 Pope Street, Christchurch, NEW ZEALAND Phone [phone] FAX [phone]

### 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 ________________________________________________________________________________________________________________________________________________ K043070

| Submitter | Canterbury Scientific Ltd<br>14 Pope Street<br>Christchurch<br>New Zealand<br>Phone [phone]<br>FAX [phone] |
|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person<br>Date of Preparation<br>Device Name<br>Common Name<br>Classification<br>Class<br>Product Code<br>Equivalent Device | Maurice Owen, PhD, Scientific Director<br>November 2, 2004<br>Liquid Stable HbA1c Control<br>HbA1c Controls<br>21CFR 862.1660 Quality Control Material (assayed and<br>unassayed)<br>1<br>JJX<br>Quantimetrix Corporation, GlycoHemosure. (510(k) # K032791) |
| Description of Device | The Liquid Stable HbA1c Control is a bi-level liquid HbA1c<br>control that is prepared from human red cells. The control<br>should be treated the same as patient specimens and tested<br>following the instructions included with the instrument, kit or<br>reagent being used. |
| Intended Use of Device | The Liquid Stable HbA1c Control is intended for use as a quality<br>control material to monitor the performance of laboratory testing<br>procedures for HbA1c quantitation. The control is designed for<br>use with lon exchange HPLC assays, Immunoassay based<br>assays and Boronate Affinity based assays. |

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practices. The two levels of controls allow performance monitoring within the clinical range.

The controls are for in vitro diagnostic use only and should not be used past the expiry date.

#### Comparison with Predicate Device

The Canterbury Scientific Ltd Liquid Stable HbA1c Control is substantially equivalent to Glycohemosure HbA1c Control manufactured by Quantimetrix Corporation. They both have the same intended application and technical characteristics.

Canterbury Scientific Ltd Liquid Stable HbA1c Control has an open vial stability of 30 days at 2°-8°C, the same as Quantimetrix's Glycohemosure. The closed vial stabilities are also identical at 18 months at 2° - 8°C.

#### Performance Characteristics

Stability studies at 20° - 25°C were performed on the Bio-Rad Variant, Bayer DCA200, Roche Hitachi 917 and Primus CLC385 to validate the open vial stability claims. Real-time studies were performed on the Bayer DCA2000 and BioRad Variant at 2°-8°C. The results support a shelf life at 2°-8°C of 18 months and an open vial claim of 30 days (at 2°-8°C).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected, flowing lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 9 2004

Maurice Owen, PhD Scientific Director Canterbury Scientific Ltd 14 Pope Street Christchurch 8001 New Zealand

Re: k043070

> Trade/Device Name: Liquid Stable HbA1c Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 3, 2004 Received: November 8, 2004

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K043070

Device Name: Liquid Stable HbA1c Control

Indications for Use:

The Liquid Stable Hemoglobin A1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based analyses and Boronate Affinity based assays.

The use of quality control materials is indicated as an objective assessment of the precision and bias 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 clinical range.

The controls are for in vitro diagnostic use only and should not be used past the expiry date.

V Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K

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