(37 days)
Not Found
No
The device description and intended use clearly indicate it is a quality control material for laboratory toxicology screening, with no mention of AI/ML or related concepts.
No
The device is a quality control urine used to monitor the performance of laboratory urine toxicology screening procedures, not to treat or diagnose a medical condition in a patient.
No
Explanation: The device is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures, not to diagnose a patient's condition. It's a control for other diagnostic tests.
No
The device description clearly states it is a liquid control material prepared from human urine with added substances, 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 clearly states it's for "monitoring the performance of laboratory urine toxicology screening procedures." This means it's used in vitro (outside the body) to assess the accuracy and reliability of tests performed on patient samples (urine).
- Device Description: It's a "quality control urine" prepared from human urine with added substances. This further confirms its use as a control material in laboratory testing.
- Care Setting: The intended user is a "laboratory," which is where IVD tests are typically performed.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Product codes
DIF
Device Description
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 product contains 0.1% sodium azide as a preservative.
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
laboratory
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K981590". The handwriting is somewhat rough, with thick strokes and some smudging, giving it a casual appearance. The characters are arranged horizontally and are easily readable.
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is in black and white, with the words "BIO-RAD" in large, bold letters. The letters are white, and they are set against a black background. The background is a rounded rectangle shape.
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.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text reads "BIO-RAD" with a plus sign between "BIO" and "RAD".
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 Liquichek
Urine Toxicology Control | Liquid Drugs of Abuse Controls
Medical Analysis Systems |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | A quality control urine to monitor
the performance of laboratory
urine toxicology confirmatory
procedures. | A consistent test sample of known
concentration for monitoring assay
conditions in quantitative and
qualitative analysis of patient urine
specimens for drug and drug
metabolites. |
| Levels | Level C1 = Drugs added at
concentrations
approximately 60%
below confirmatory
cutoffs or at LOQ
Level C2 = Drugs added at
concentrations
20-25% below
confirmatory cutoffs
Level C3 = Drugs added at
concentrations
20-25% above
confirmatory cutoffs
Level C4 = Elevated confirmatory
control | Level G2 = 20-25% below
GC/MS cutoff
Level G3 = 20-25% above
GC/MS cutoff
Level G4 = Elevated
GC/MS |
| Form | Liquid | Liquid |
| Open
Vial
Claim | 30 Days at 2-8°C | 30 Days at 2-8°C |
| Matrix | Human Urine | Human Urine |
| Storage | 2-8°C | 2-8°C |
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's head, body, and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
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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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/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
4
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()