(37 days)
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience.
This document is a 510(k) summary for the Bio-Rad Liquichek Urine Toxicology Control, a quality control urine intended to monitor the performance of laboratory urine toxicology screening procedures. It does not provide information about a study that assesses the performance of a device against acceptance criteria in the manner described in the request.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document focuses on demonstrating substantial equivalence to existing predicate devices (Liquid Drugs of Abuse Controls, Medical Analysis Systems, K903430), rather than outlining performance against specific acceptance criteria for a new device's functionality. The tables within the document compare the technological characteristics and intended use of the Bio-Rad product to the predicate device, which is a different type of evaluation from a performance study.
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aboratories
ine, California 92618-2017 Telephone: (714) 598-1200
JUN 10 1998
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation April 30, 1998
Device (Trade & Common Name) Liquichek Urine Toxicology Control
Classification Name Class 1, CFR 862.3280: Drug Mixture Control 91DIF
Devices to Which Substantial Equivalence is Claimed Liguid Drugs of Abuse Controls Medical Analysis Systems, Camarillo, California K903430
Statement of Intended Use Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Description of the Device
Liquichek Urine Toxicology Control is prepared from human urine with added drugs, drug metabolites, preservatives and stabilizers. The control is provided in liquid form for convenience.
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek Urine Toxicology Control and the devices to which substantial equivalence is claimed.
| Bio-Rad LiquichekUrine Toxicology Control | Liquid Drugs of Abuse ControlsMedical Analysis Systems | |
|---|---|---|
| IntendedUse | A quality control urine to monitorthe performance of laboratoryurine toxicology confirmatoryprocedures. | A consistent test sample of knownconcentration for monitoring assayconditions in quantitative andqualitative analysis of patient urinespecimens for drug and drugmetabolites. |
| Levels | Level C1 = Drugs added atconcentrationsapproximately 60%below confirmatorycutoffs or at LOQLevel C2 = Drugs added atconcentrations20-25% belowconfirmatory cutoffsLevel C3 = Drugs added atconcentrations20-25% aboveconfirmatory cutoffsLevel C4 = Elevated confirmatorycontrol | Level G2 = 20-25% belowGC/MS cutoffLevel G3 = 20-25% aboveGC/MS cutoffLevel G4 = ElevatedGC/MS |
| Form | Liquid | Liquid |
| OpenVialClaim | 30 Days at 2-8°C | 30 Days at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
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JUN 1 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt . Acting Regulatory Affairs/Quality Assurance Bio Rad Laboratories 9500 Jeronimo Road 92618-2017 Irvine, California
K981590 Re : Liquichek Urine Toxicology Control Requlatory Class: I Product Code: DIF Dated: April 30, 1998 Received: May 4, 1998
Dear Ms. Platt:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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/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
K9 Y 1590
Liquichek Urine Toxicology Control Device Name:
Indications for Use:
510(k) Number:
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981159()
§ 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.