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.

Device Description

The Liquid Stable HbA1c Control is a bi-level liquid HbA1c control that is prepared from human red cells. The control should be treated the same as patient specimens and tested following the instructions included with the instrument, kit or reagent being used.

AI/ML Overview

The provided text describes a 510(k) summary for a "Liquid Stable HbA1c Control" device. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, many of the typical acceptance criteria and study elements associated with AI diagnostic devices (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, and training/test sets) are not applicable here.

Instead, the "acceptance criteria" for a quality control material primarily revolve around its stability and performance characteristics in monitoring laboratory testing procedures. The study described focuses on validating these stability claims.

Here's an adaptation of the request to fit the context of a quality control material:

1. Table of Acceptance Criteria (or Performance Claims) and Reported Device Performance

Feature/Claim	Acceptance Criteria or Predicate Device Performance	Reported Device Performance
Open Vial Stability	30 days at 2°-8°C (Same as predicate)	Validated as 30 days at 2°-8°C
Closed Vial Stability	18 months at 2°-8°C (Same as predicate)	Validated as 18 months at 2°-8°C
Intended Use	Monitor HbA1c quantitation performance	Intended for use with specified assay types (HPLC, Immunoassay, Boronate Affinity)

2. Sample size used for the test set and the data provenance

Test Sample: The "test set" in this context refers to the Liquid Stable HbA1c Control material itself, which was subjected to stability testing. The document does not specify a "sample size" in terms of individual patient samples or measurements beyond the stability data.
Data Provenance: The document does not specify the country of origin for any human data, as it's a quality control material. The data provenance relates to the stability testing done on the control material itself.
- Specificity: Stability studies were performed on various laboratory instruments (Bio-Rad Variant, Bayer DCA200, Roche Hitachi 917, Primus CLC385, Bayer DCA2000). The context implies these were conducted in a laboratory setting by the manufacturer, Canterbury Scientific Ltd.
- Retrospective or Prospective: The stability studies were prospective, as they involved real-time and accelerated (20°-25°C) testing over time to determine shelf life.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable for a quality control material. "Ground truth" in the context of diagnostic AI typically refers to a definitive diagnosis or measurement for a patient sample. For a quality control material, its "truth" is its stability and its ability to consistently perform within expected ranges when used to monitor assays. The "truth" is established through documented laboratory methods and instrument validations.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of patient data (e.g., medical images). For stability testing of a control material, the results are quantitative measurements against predefined criteria, not subjective interpretations 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 device is a quality control material, not an AI-powered diagnostic tool, and it does not involve human readers interpreting cases or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. It's a laboratory reagent.

7. The type of ground truth used

For the stability studies, the "ground truth" implicitly refers to the established scientific principles of chemical and biological stability and the performance of the control material over time when stored under specified conditions and tested on validated laboratory instruments. The "truth" is that the material retains its expected properties (e.g., target HbA1c values) within acceptable variation over the claimed stability period.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established

Not applicable. No training set exists for this device.

Summary

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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 +64 3 343 3345 FAX +64 3 343 3342

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 Ltd14 Pope StreetChristchurchNew ZealandPhone +64 3 343 3345FAX +64 3 343 3342
Contact PersonDate of PreparationDevice NameCommon NameClassificationClassProduct CodeEquivalent Device	Maurice Owen, PhD, Scientific DirectorNovember 2, 2004Liquid Stable HbA1c ControlHbA1c Controls21CFR 862.1660 Quality Control Material (assayed andunassayed)1JJXQuantimetrix Corporation, GlycoHemosure. (510(k) # K032791)
Description of Device	The Liquid Stable HbA1c Control is a bi-level liquid HbA1ccontrol that is prepared from human red cells. The controlshould be treated the same as patient specimens and testedfollowing the instructions included with the instrument, kit orreagent being used.
Intended Use of Device	The Liquid Stable HbA1c Control is intended for use as a qualitycontrol material to monitor the performance of laboratory testingprocedures for HbA1c quantitation. The control is designed foruse with lon exchange HPLC assays, Immunoassay basedassays 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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 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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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.