POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER by ARKRAY, INC.

The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the SpotChem EZ Analyzer and ALT Test. It acknowledges that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer the prompt thoroughly.

The letter primarily focuses on the regulatory classification and marketing authorization, not on the specific performance studies. Therefore, much of the requested information is absent from this document.

Here's what can be extracted, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in this document.
Reported Device Performance: Not detailed in this document. The letter only states that the device is "substantially equivalent" to a predicate device, implying its performance should be comparable, but no specific metrics are provided.

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

Sample Size: Not available in this document.
Data Provenance: Not available in this document.

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

Not available in this document.

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

Not available in this document.

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 device is an in-vitro diagnostic analyzer for enzyme activity (ALT/SGPT), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This device is a standalone instrument for measuring enzyme activity. Its performance would inherently be "standalone" in the sense that it doesn't involve a human interpreting its output in the context of an algorithm's assistance. However, the exact study details are not provided.

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

For an ALT test, the "ground truth" would typically be established by a reference method of ALT measurement, often a well-established enzymatic kinetic assay, which is considered the gold standard for accurately determining enzyme activity in a sample. This document does not specify the method.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device that requires a training set in that context. If we interpret "training set" broadly as the data used to validate the initial assay, that information is not present.

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

Not applicable for the same reasons as point 8.

Summary of what can be inferred or is explicitly stated:

Device Name: SpotChem EZ Analyzer and ALT Test
Intended Use: To measure the activity of the enzyme alanine amino transferase (ALT or SGPT) in serum, plasma, and whole blood for the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Regulatory Status: Substantially Equivalent (510(k) clearance) to legally marketed predicate devices.
Regulatory Class: Class I
Product Codes: CKA (Alanine amino transferase (ALT/SGPT) test system) and JJF.
Manufacturer: ARKRAY, Inc.

To fully answer your prompt, you would need to consult the actual 510(k) submission document (K040332) which would contain the detailed pre-market performance data submitted by the manufacturer to the FDA. This letter only provides the outcome of the FDA's review.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2005

Mr. Yuji Yagi ARKRAY, Inc. 57 Nishiaketa-Cho. Higashi-Kujo, Minami-Ku Kyoto, Japan 601-8045

K040332 Trade/Device Name: SpotChem EZ Analyzer and ALT Test Regulation Number: 21 CFR 862.1030 Regulation Name: Alanine amino transferase (ALT/SGPT) test system Regulatory Class: Class I Product Code: CKA, JJF Dated: April 6, 2004 Received: April 27, 2004

Dear Mr. Yagi:

Re:

This letter corrects our substantially equivalent letter of April 6, 2004 regarding the applicant/ owner which should be listed as Arkray and not Polymedco.

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 (Act 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 and to 895. In additions and to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 not 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).

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 the more of (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Cornelia B. Pookt

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

Cc: Polymedco, Inc Helen Landicho, RAC

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Indications for Use

510(k) Number (if known): K040332

Device Name:_SpotChem EZ Analyzer and ALT Test

Indications For Use:

Prescription Use V (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 C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040332

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Regulation Number and Section

§ 862.2170 Micro chemistry analyzer for clinical use.

(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.