(98 days)
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Not Found
No
The summary describes a qualitative immunoassay for detecting drug metabolites, which is a standard biochemical test and does not mention any AI/ML components or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is an immunoassay for detecting drug metabolites, intended for diagnostic or screening purposes, not for treating a disease or condition.
Yes
This device is an immunoassay designed to qualitatively detect specific metabolites in urine, which is a diagnostic function used to identify the presence of Phencyclidine metabolites.
No
The device description is not found, but the intended use clearly describes an immunoassay that detects substances in urine, which is a physical test requiring hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "immunoassay that qualitatively detects the major Phencyclidine metabolites in urine". This indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting drug metabolites).
- Specimen Type: The device analyzes urine, which is a biological specimen from the human body.
- Purpose: The purpose is to detect the presence of Phencyclidine metabolites, which is a diagnostic test for drug use.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description.
N/A
Intended Use / Indications for Use
The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.
Product codes
LCM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 5 1999
Mr. Roy Chung President Microdiagnostics, Inc. 28062 Forbes Road, Suite B Laguna Niguel, California 92677
Re: K991505
Trade Name: MICRO-STRIP FOR PHENCYCLIDINE METABOLITES Regulatory Class: II Product Code: LCM Dated: July 15, 1999 Received: July 19, 1999
Dear Mr. Chung:
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 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). 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 regulations.
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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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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510(k) NUMBER (IF KNOWN): _K991505 MICRO_STRIP FOR PHENCYCLIDINE METABOLITES DEVICE NAME: INDICATIONS FOR USE: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.
Tean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K 991505
(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) $\checkmark$
OR
Over-The-Counter-Use (Optional Format 1-2-96)