(38 days)
K-971691
K-971691
No
The 510(k) summary describes a quality control material for drug testing, not a device that processes data or makes decisions using AI/ML. There is no mention of AI, ML, or related concepts.
No
This device is a quality control material intended to monitor the performance of drug-of-abuse testing procedures, not to treat or diagnose a disease or condition.
No
Explanation: This device is a quality control material used to monitor the performance of drug testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a liquid human urine based assayed quality control material, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures." These testing procedures are performed in vitro (outside the body) on biological samples (urine).
- Device Description: The description confirms it's a "liquid human urine based assayed quality control material." This material is used in vitro to assess the accuracy and reliability of diagnostic tests.
- Intended User / Care Setting: It's intended for "Laboratory testing procedures," which are typically where in vitro diagnostics are used.
- Predicate Device: The mention of a predicate device (K-971691 LIQUICHEK™ URINE TOXICOLOGY CONTROLS) which is also a quality control for urine toxicology testing, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically other IVDs.
In summary, the device is a control material used in vitro to evaluate the performance of diagnostic tests performed on biological samples, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor and evaluate the precision and the accuracy of laboratory testing procedures for the analytes listed in the package insert.
Product codes
DIF
Device Description
Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures.
Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains
§ 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
Product Performance and Substantial Equivalency
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K9239 5
| Submitter: |
|---|
| SeraCare Technology, Inc. DBA Consolidated Technologies |
| 2170 Woodward Street |
| Austin, TX 78744-1832 |
| Phone: (512) 445-5100 |
| Fax: (512) 445-5515 |
Contact: Rusty Sewell Preparation date: July 13, 1999
Product name (trade & common):
Proprietary: Urine Drug Screening Control Common: Not Applicable
Classification name:
Class 1 , Product code: DIF 21 CFR 862:3280 : Quality Control Material (Assayed and Unassayed)
Predicate device:
LIQUICHEK™ URINE TOXICOLOGY CONTROLS BIO-RAD Laboratories K-971691
Device description:
Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures.
Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains Dated: July 13, 1999 Received: July 19, 1999
Dear Mr. Sewell:
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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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 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 Sutman
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
4
INDICATIONS FOR USE STATEMENT
510(k) number (if known): K 99 23415
Urine Drug Screening Control Device name:
Indications for use:
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madin
(Division Sign-Division of Clinical La 510(k) Numb
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