TC MATRIX CLINICAL CHEMISTRY ANALYZER by TECO DIAGNOSTICS

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO MULTI Calibrator is intended for the calibration of quantitative assays.

Teco Albumin reagent is intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Teco ALT reagent is intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Teco Glucose reagent is intended for the quantitative determination of total glucose in human serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Teco BUN reagent is intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

AI/ML Overview

This FDA 510(k) clearance letter pertains to the TC Matrix Clinical Chemistry Analyzer and several associated reagents. It does not contain a study that proves the device meets acceptance criteria, nor does it provide details on specific acceptance criteria and device performance.

The letter primarily confirms that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use stated in the enclosure.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

Here's a breakdown of what can be inferred or is explicitly stated:

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

Not available in the provided document. The letter makes a determination of substantial equivalence based on the indications for use, but it does not present a table of specific performance criteria or the results of a study demonstrating these. Such information would typically be in the 510(k) submission itself, not the FDA's clearance letter.

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

Not available in the provided document.

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 available in the provided document.

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

Not available in the provided 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:

Not applicable/available. This device is a clinical chemistry analyzer, not an AI-assisted diagnostic imaging system that involves human readers in the way an MRMC study would measure.

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

Not applicable in the context of an "algorithm only". The device itself is an automated analyzer. Its performance is inherent to the analyzer's function, not a standalone "algorithm" in the typical sense of AI. The performance comparison would be between this analyzer and a predicate device or established reference methods. While the letter confirms substantial equivalence, it doesn't detail the studies.

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

Not available in the provided document. For a chemistry analyzer, ground truth would typically be established by comparing results to a recognized reference method or a predicate device.

8. The sample size for the training set:

Not applicable/available. As a clinical chemistry analyzer, this device does not typically have a "training set" in the machine learning sense. Its calibration and performance are established through analytical verification and validation studies using known controls, calibrators, and patient samples.

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

Not applicable/available. See point 8.

Summary from the document:

Device Name: TC Matrix Clinical Chemistry Analyzer
Function: A discrete photometric chemistry analyzer intended to automate manual analytical procedures (pipetting, heating, measuring color intensity) for measuring various analytes in serum and plasma samples.
Intended Use of specific reagents mentioned:
- TECO MULTI Calibrator: For calibration of quantitative assays.
- Teco Albumin reagent: To measure albumin concentration in serum and plasma for diagnosing liver or kidney diseases.
- Teco ALT reagent: To measure alanine amino transferase (ALT) activity in serum and plasma for diagnosing liver and heart diseases.
- Teco Glucose reagent: For quantitative determination of total glucose in human serum or plasma for diagnosing and treating carbohydrate metabolism disorders (e.g., diabetes mellitus).
- Teco BUN reagent: To measure urea nitrogen in serum or plasma for diagnosing and treating renal and metabolic diseases.
FDA Determination: Substantially equivalent to legally marketed predicate devices. This means the FDA believes it performs as intended and is as safe and effective as existing devices on the market for its stated indications.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Teco Diagnostics c/o Ms. Jian Vaeches R & D Department 1268 North Lakeview Avenue Anaheim, CA 92807

MAY - 8 2008

K073370 Re:

Trade Name: TC Matrix Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, CKA, CIX, CDQ, JJE, JIX Dated: March 12, 2008 Received: March 24, 2008

Dear Ms. Vaeches:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your booms in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manative to of the Medical Device American Drug commerce prof to May 20, 1770, the chaomen and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costletic Act (Act) that to not roquire approvine of the general controls provisions of the Act. The Act. The You may, merelore, market the device, basyon to me ments for annual registration, listing of general controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (soo aoove) inro . Existing major regulations affecting your device It may be subject to such additional comeonal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Codo of Federal resguents.
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 Please be advised that I DA s issualled of a but one complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a determination and Jour Stered by other Federal agencies. You must in and lisit of any Federal statutes and regulations annings, but not limited to: registration and listing (21 comply with an the Ace 3 requirements, includes 3).
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), laboning (21 Ce 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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) :

Device Name: TC Matrix Clinical Chemistry Analyzer

Indications for Use:

TECO MULTI Calibrator is intended for the calibration of quantitative assays.

Prescription Use J ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109)

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

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

Division Sign-Off
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Office of In Vitro Diagnostic Device
Evaluation and Safety
K073370

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Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
Identification. A discrete photometric 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. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.