(111 days)
Not Found
Not Found
No
The summary describes a homogeneous immunoassay for detecting cotinine in urine, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is an in vitro diagnostic immunoassay used for the qualitative and semiquantitative analysis of cotinine in human urine, which means it detects substances in the body for diagnostic purposes, rather than treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states it is an "immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine" and that it is "useful in the detection of cotinine after ingestion of or exposure to nicotine." It also explicitly states "For In Vitro Diagnostic Use." This indicates its purpose is to diagnose exposure to nicotine.
No
The device is an immunoassay kit for analyzing cotinine in urine, which is a laboratory test involving chemical reagents and potentially hardware for analysis, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use." This is the primary indicator that the device is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Furthermore, the device analyzes a human specimen (urine) to detect a substance (cotinine) related to a physiological state (nicotine exposure), which aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.
Product codes
MKU
Device Description
Not Found
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPT. OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.
OCT 2 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
R.Sam Niedbala, Ph.D. . Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
K972481 Re : STC Auto-Lyte® Cotinine EIA Regulatory Class: II MKU Product Code: Dated: July 1, 1997 Received: July 2, 1997
Dear Dr. Niedbala:
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, qood 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. ਕੇ 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 requlation 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 geference to
premarket notification" (21 CPR 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 Ditman
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
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _ Auto-Lyte® Cotinine EIA________________________________________________________________________________________________________________________________________
Indications For Use: The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboraton Devices
510(k) Number. K92481
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
c:\fda\indica.doc