(14 days)
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.
ONTRAK TESTCUP™ and TESTSTIK Controls
I am sorry, but the provided text from the FDA 510(k) letter for the ONTRAK TESTCUP® AND TESTSTIK Controls does not contain the specific information required to complete your request about acceptance criteria and a study proving device performance.
The document is a clearance letter indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not include:
- Acceptance criteria and reported device performance: This information would typically be found in a summary of the device's performance data, not in the regulatory clearance letter itself.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, type of ground truth, training set sample size, or how training ground truth was established. These details are part of a technical study report that supports the 510(k) submission, not the clearance letter.
Therefore, I cannot fulfill your request based on the provided text.
{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.
{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 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
{2}------------------------------------------------
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
§ 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.