CHEMISTRY CALIBRATOR by JAS Diagnostics, Inc.

Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Chemistry Calibrator. This device is a calibrator intended for use in calibrating multiple in vitro quantitative chemistry assays on automated chemistry analyzers.

Based on the information provided, this document addresses a diagnostic device that performs calibration, not an AI/ML-driven device or study evaluating human reader performance. Therefore, most of the requested information (acceptance criteria, device performance metrics, study design elements for AI/ML, human reader studies, etc.) is not applicable or extractable from this regulatory document.

However, I can extract information related to the device type and its intended use.

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

This document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a performance study report. For a calibrator, acceptance criteria would typically involve accuracy, precision, linearity, and stability, but these are not present here.

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

Not applicable. This document does not describe a clinical study or a test set as defined for AI/ML performance evaluation. Calibrator performance is typically evaluated by methods like linearity, recovery studies, and value assignment, not through test sets with human specimens in the context of diagnostic accuracy.

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)

Not applicable. Ground truth in the context of calibrators refers to the accurately assigned values for the analytes within the calibrator, which are established through certified reference materials and rigorous analytical methods, not typically by expert consensus in the diagnostic sense implied by the question.

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

Not applicable.

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

No. This device is a chemical calibrator, not an AI/ML diagnostic algorithm that would be used by human readers.

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

Not applicable. This is a physical chemical calibrator, not an algorithm.

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

For a chemical calibrator, the "ground truth" for its assigned values would be established through traceability to internationally recognized reference materials and/or methods, often involving multiple reference laboratories and certified analytical techniques. This is a metrological concept, distinct from clinical ground truth like pathology or expert consensus. The document does not specify how the values for this particular calibrator were established.

8. The sample size for the training set

Not applicable. There is no "training set" for a chemical calibrator in the sense of AI/ML.

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

Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, with their arms raised.

Food and 'Drug Administration

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR = 8 2002

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

Re: K020454

Trade/Device Name: JAS Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: January 24, 2002 Received: February 11, 2002

Dear Mr. Johnston:

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 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 1 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, ( Jease 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/cdrb/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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Page 1 of 1

510(k) Number (if known): N/A Device Name: 45 CHEMISTRY CALIBRATOR Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory
510(k) Number K00205

ﺎ ﮨﮯ Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.