ONE STEP MARIJUANA CARD TEST by TECO DIAGNOSTICS

This document is a 510(k) clearance letter from the FDA for a medical device called the "OneStep Marijuana (THC) Card Test." It does not contain a detailed study report with acceptance criteria and performance data. Therefore, I cannot provide accurate information for most of the requested points.

However, based on the limited information in the document, here's what can be inferred or stated about the device and its clearance:

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

This information is not available in the provided document. The 510(k) letter is a notice of substantial equivalence, not a detailed performance study report. It indicates that the FDA has reviewed the manufacturer's submission which would have contained this data, but the data itself is not presented here.

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

This information is 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):

This information is not available in the provided document.

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

This information is 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:

This is irrelevant for this device. The "OneStep Marijuana (THC) Card Test" is described as a "rapid, competitive binding immunoassay for qualitative determination of tetrahydrocannabinol (THC) metabolites in urine." This is a diagnostic test kit, not an AI-powered image analysis or diagnostic tool that would involve "human readers" or AI assistance in that context. Therefore, an MRMC study and AI improvement effect size are not applicable.

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

The device is an immunoassay card test, which inherently has a "human-in-the-loop" component (someone applying the sample and interpreting the result). The concept of a "standalone algorithm" is not applicable to this type of device. The performance data submitted to the FDA would have evaluated the device's ability to detect THC metabolites, which is its standalone function.

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

For a drug test like this, the ground truth would typically be established by confirmatory laboratory methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS)) performed on the same urine samples. This information is not explicitly stated in the provided document but is the standard for such devices.

8. The sample size for the training set:

This information is not available in the provided document. While the manufacturer would have used a training set during development, the 510(k) letter does not detail this.

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

This information is not available in the provided document. Similar to the test set, it would likely involve confirmatory laboratory methods.

In summary, the provided document is an FDA 510(k) clearance letter and not a detailed study report. Therefore, most of the specific information requested about acceptance criteria, sample sizes, expert qualifications, and study methodologies is not present within this document. The letter confirms the device's substantial equivalence to a predicate device based on data submitted by the manufacturer, but it does not present that data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal for the Department of Health and Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized eagle design, which is a common symbol used in US government seals.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Andrew Reams Official FDA Correspondent Teco Diagnostics ……………… : 4925 E. Hunter Avenue Anaheim, California 92807

JUL ** 3 1997

. ...

Re : K970548 OneStep Marijuana (THC) Card Test Requlatory Class: II Product Code: LDJ April 28, 1997 Dated: Received: May 2, 1997

Dear Mr. Reams:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturinq practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as wor 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 additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

{2}------------------------------------------------

/01/96 14:

14:38 8301 594 5941 CDRH ODE

K.970548

[?]002

Page of

510(k) Number (if known):
Device Name: One Stop Marijuana Card Test
Indications For Use:
A rapid, competetitke binding
immunoassay for qualitative determination
of tetrahydrocannabinol (THC)
metabolites in Urine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division

Numb: K970048

Prescription Use /
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
is 6/30/27
(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).