URS-1B (BLOOD TEST) by TECO DIAGNOSTICS

The TECO Diagnostics URS-1B (Blood Test) is intended for "Professional Use." The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a medical device called URS-1B (Blood Test) by Teco Diagnostics. It states that the device is substantially equivalent to a predicate device for the qualitative determination of blood in human urine for professional use.

However, the provided document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is primarily an FDA clearance letter, confirming substantial equivalence to a predicate device, and includes the indications for use. It does not elaborate on the specific performance studies that led to this clearance.

Therefore, most of the information requested cannot be extracted from the given text.

Here is what can be inferred or stated based on the provided text, with the understanding that much of the request cannot be fulfilled:

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

Cannot be provided. The document does not specify quantified acceptance criteria or detailed performance metrics from a study (e.g., sensitivity, specificity, accuracy). It only states that the device is "substantially equivalent" to a legally marketed predicate device.

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

Cannot be provided. This information is not present in the FDA clearance letter.

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):

Cannot be provided. This document does not detail how ground truth was established for any studies, nor does it mention experts or their qualifications.

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

Cannot be provided. This information is not present in the FDA clearance letter.

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:

Cannot be provided. This device is a "Blood Test" (likely an in-vitro diagnostic strip or similar), not an AI-assisted imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

Cannot be provided directly. While the device itself would have a standalone performance, the specific study details (if one was done in this context) are not described in this document. Given it's a qualitative test for "Professional Use," it implies the professional interprets the result, so a true "algorithm only without human-in-the-loop" study in the AI sense is unlikely.

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

Cannot be provided. The document does not specify the method for establishing ground truth for any studies. For a qualitative blood test for hematuria, ground truth would typically be established by a more definitive laboratory method or clinical diagnosis, but this is not detailed here.

8. The sample size for the training set:

Cannot be provided. This document is silent on any training sets or their sizes.

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

Cannot be provided. This document is silent on any training sets or their ground truth establishment.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 0 6 2003

Ms. Lisa To Official FDA Correspondent Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807

Re: K023297

Trade/Device Name: URS-1B (Blood Test) Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: JIO Dated: December 16, 2002 Received: December 23, 2002

Dear Ms. To:

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 yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 3

INDICATIONS FOR USE STATEMENT

510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Stau Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KD23297

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.