The Compass Bioscience Hemoglobin A1c Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure Hemoglobin A1c levels. It is intended to validate the measurement of Hemoglobin A1c in patient samples.

Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

Device Description

The Compass Bioscience Hemoglobin A1c Control is supplied as frozen liquid in two levels and consists of a human whole blood matrix adjusted to target concentrations of glycated hemoglobin (HbA1c) and containing preservatives and stabilizers. Assayed values are determined from interlaboratory data.

Hemoglobin A1c Assayed Controls are supplied in two levels, 3 x 1 mL each level per box . The controls are supplied as a ready-to-use frozen liguid, requiring no reconstitution or dilution. They are prepared in a human whole blood matrix adjusted to target concentrations of HbA1c. Stabilizers and preservatives have been added to inhibit microbial growth.

AI/ML Overview

This submission describes a Hemoglobin A1c Assayed Control (K060570) and its substantial equivalence to an existing predicate device for quality control in laboratory settings. The performance criteria and testing focus on product stability rather than diagnostic accuracy as the device is a control material, not a diagnostic test.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Failure Criterion)	Reported Device Performance
Closed Vial Stability (-15°C to -25°C):
Analate recovery >10% compared to initial value ± highest allowable instrument/reagent imprecision	2 years (based on accelerated stability studies; real-time testing ongoing)
Closed Vial Stability (2-8°C):
Analate recovery >10% compared to Day 0 value after 35 days of storage at 20-25°C (accelerated testing)	12 months (passed stability within ±10% recovery after 35 days at 20-25°C)
Open Vial Stability (2-8°C):
Analate recovery >10% compared to Day 0 value after 88 days of storage at 2-8°C	90 days (passed stability within ±10% recovery after 88 days at 2-8°C)
Open Vial Stability (20-25°C):
Analate recovery >10% compared to Day 0 value after 10 days of storage at 20-25°C	7 days (passed stability within ±10% recovery after 10 days at 20-25°C)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify the exact number of individual samples or vials tested for each stability study. It mentions testing "multiple lots of product" for open vial stability but does not provide a specific number.
Data Provenance: The studies are described as "accelerated stability studies" and "real-time stability testing." Given the context of a 510(k) submission to the FDA, it is highly likely these studies were conducted in the US (where Compass Bioscience is based). The studies appear to be prospective, as they involve monitoring the product over time under defined storage conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this submission. The device is a quality control material, not a diagnostic device requiring expert interpretation of results. The "ground truth" for the test set (stability studies) is defined by the initial concentration of HbA1c in the control material and its change over time, or by interlaboratory assayed values.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this submission as there is no human interpretation or adjudication of performance based on the type of data presented (stability measurements).

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

This is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the stability studies is primarily:

Initial test value: The concentration of HbA1c in the control material at the start of the stability study (day 0).
Interlaboratory data: For assayed values, the ground truth is established collectively from interlaboratory studies using various instrument manufacturers' reagents. This represents a consensus of measured values across different laboratory settings.

8. The sample size for the training set

This is not applicable. The device is a quality control material, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

Summary

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K06057$

Prepared: 2/22/2006 Submitted by: Evy K. Johnson Establishment Address: Compass Bioscience 1850 Evergreen Street Duarte CA 91010 phone: 626.359.9645 626.359.7697 fax:

APR 1 3 2006

Establishment Registration Number: 2032652

Contact Person: Dr. Carter Grandjean

Proprietary (Trade) Name:

Common Name: Hemoglobin A1c Assayed Control

Classification Name: Single Analyte Controls, All Kinds (assayed and unassayed) 75 JJX

Classification: Class I

Substantial Equivalence:

The Compass Bioscience controls are substantially equivalent to other such controls in general use, such as the MAS Diabetes Control, sold by Medical Analysis Systems, which is supplied liquid in two levels as a human whole blood matrix adjusted to specific concentrations of glycated hemoglobin.

Description:

Intended Use:

The Compass Bioscience Hemoglobin A1c Assayed Controls are intended for use as quality control materials to assess the accuracy and precision of assay procedures for HbA1c used in individual laboratories.

Technological Characteristics Compared to Predicate Devices:

The Compass Bioscience control product employs a similar matrix and constituent formulation to the equivalent predicate device listed above: human whole blood matrix with adjusted (HBA1c) levels containing stabilizers and preservatives. The Compass Bioscience Control also has similar storage and stability requirements as the equivalent devices.

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Performance Characteristics:

The closed vial stability claim made for this product is 2 years when stored at -15° C to -25° C, based on accelerated stability studies.2 The Hemoglobin A1c control was stored at 2-8°C to simulate 2 years storage at -15°C to -25° C. An increase or decrease of >10% of analyte recovery compared to the initial test value ± the highest allowable instrument/reagent imprecision was used as the analyte failure criterion for determining shelf life. Real time stability testing is ongoing on multiple lots of product.

The closed vial stability claim for this product when stored at 2-8° C is 12 months. Accelerated stability testing at 20 - 25° C was used to determine the closed vial refrigerated shelf life. The Hemoglobin A1c Control was stored at 20 - 25° C and the recovery (vs. day 0) was measured in intervals of 7 days. The product passed stability if its recovery was within ±10% of the day 0 value after 35 days of storage at 20 - 25° C.

The open vial stability claim for this product is 90 days when stored at 2 - 8° C. Real time testing of vials opened, warmed to room temperature, sampled, and returned to the refrigerator, and re-used at various intervals in the same manner was performed and measured against freshly opened vials. The product passed stability if its recovery was within ±10% of the Day 0 value after 88 days of storage at 2 - 8° C. Multiple lots of product were tested with no significant difference in performance.

The open vial stability claim for this product is 7 days when stored at 20 - 25° C (Room Temperature). Real time testing of vials opened, sampled, re-capped, and re-used at various intervals in the same manner was performed and measured against freshly opened vials. The product passed stability if its recovery was within ±10% of the day 0 value after 10 days of storage at 20 - 25° C. Multiple lots of product were tested with no significant difference in performance.

The equivalent predicate device, MAS Diabetes Control, claims a 2 year shelf life for storage at -20° C and a 14 day opened/closed vial stability at refrigerated (2 - 8° C) storage.

Assayed Values

Assay values were established from interlaboratory data using instrument manufacturers' reagents. Mean values and expected ranges for the listed lots of controls were calculated from reagent lots available at the time of assay.

2 L. Kennon, Stability Prediction Model, Journal of Pharmaceutical Sciences 53:7, 815-818, 1964.

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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 and Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is positioned to the right of a circular border containing the text "U.S. Department of Health and Human Services". The text is arranged around the circumference of the circle.

Public Health Service

APR 1 3 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Evy Johnson Chief Operating Officer Compass Bioscience 1850 Evergreen Street Duarte CA, 91010

K060570 Re:

Trade/Device Name: Hemoglobin Alc Assayed Control Regulation Number: 21 CFR§ 862.1660 Regulation Name: Quality control material Regulatory Class: Class I Product Code: JJX Dated: February 28, 2006 Received: March 7, 2006

Dear Ms. Johnson:

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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Page 2 -

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. 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): K060570

Device Name: Hemoglobin A1c

Indications For Use:

Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) K060570

Page 1 of 1

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.