K Number
K983387
Device Name
ONTRAK TESTCUP AND TESTSTIK CONTROLS
Date Cleared
1998-10-09

(14 days)

Product Code
Regulation Number
862.3280
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ONTRAK TESTCUP and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples for use with the ONTRAK TESTCUP and TESTSTIK systems for amphetamine, cocaine, cannabinoids (THC), morphine, phencyclidine (PCP), and barbiturates.
Device Description
ONTRAK TESTCUP™ and TESTSTIK Controls
More Information

Not Found

Not Found

No
The summary describes in vitro diagnostic devices for drug testing and does not mention any AI or ML components.

No
This device is described as an "in vitro diagnostic device" used for quality control samples with drug testing systems, not for treating a disease or condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "in vitro diagnostic devices."

No

The device description explicitly states "ONTRAK TESTCUP™ and TESTSTIK Controls," which are physical in vitro diagnostic devices, not software.

Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section clearly says: "The ONTRAK TESTCUP and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples..."

The "Intended User / Care Setting" section also lists "in vitro diagnostic devices".

N/A

Intended Use / Indications for Use

The ONTRAK TESTCUP and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples for use with the ONTRAK TESTCUP and TESTSTIK systems for amphetamine, cocaine, cannabinoids (THC), morphine, phencyclidine (PCP), and barbiturates.

Product codes

DIF

Device Description

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Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(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 the limitations in § 862.9.

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

0 1008 OCT

Maria Feijoo Manager, Regulatory Affairs Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re : K983387 ONTRAK TESTCUP® AND TESTSTIK Controls Regulatory Class: I Product Code: DIF Dated: September 24, 1998 Received: September 25, 1998

Dear Ms. Feijoo:

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, Drug, and Cosmetic Act (Act). 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 (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. ਸੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.

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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 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 diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 Litman

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) K 18387

ONTRAK TESTCUP™ and TESTSTIK Controls Device Name:

Indications for Use:

The ONTRAK TESTCUP and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples for use with the ONTRAK TESTCUP and TESTSTIK systems for amphetamine, cocaine, cannabinoids (THC), morphine, phencyclidine (PCP), and barbiturates.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Counter Use (Per 21 CFR 801.109) Format 1-2-96)

OR

Over-The-

(Optional

(Division Sign-Off)
Division of Clinical Laboratoi, vices
510(k) Number K 983387