(26 days)
Not Found
No
The summary describes a quality control material for laboratory testing, not a device that processes data or makes decisions using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
This device is a control used to monitor the performance of laboratory urine toxicology screening procedures, not to treat or diagnose a patient.
No.
The device is a quality control material used to monitor the performance of laboratory urine toxicology screening procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a liquid control material prepared from human urine with added constituents, 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 a "quality control urine to monitor the performance of laboratory urine toxicology screening procedures." This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: It's a prepared control material derived from human urine with added substances, designed to be used in a laboratory setting.
- Intended User / Care Setting: It's intended for use in a "laboratory," which is a typical setting for IVD testing.
The purpose of this device is to ensure the accuracy and reliability of laboratory tests performed on urine samples to detect drugs. This falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Product codes
91DIF
Device Description
Liquichek™ Urine Toxicology Control Levels S1, S2 and S3 are prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers.
The control is provided in liquid form for convenience.
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)
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Toxicology Control. Product claims are as follows:
- 2.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 2.2 Shelf Life: 24 months when stored at 2-8°C
Real time studies will be ongoing to support the shelf life of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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
MAY 29 2002
K02/411
Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1, S2 and S3
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Ofelia Cachola Regulatory Affairs Specialist Telephone: (949) 598-1287
Date of Summary Preparation
May 1, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Urine Toxicology Control Levels
S1, S2 and S3 |
|---------------------|-------------------------------------------------------------|
| Common Name: | Drug Mixture Controls |
| Classifications: | Class I |
| Product Code: | 91DIF |
| Regulation Number: | CFR 862.3280 |
Device to Which Substantial Equivalence is Claimed 3.0
Liquichek™ Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K991558
4.0 Description of Device
Liquichek™ Urine Toxicology Control Levels S1, S2 and S3 are prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers.
The control is provided in liquid form for convenience.
1
5.0 Statement of Intended Use
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Comparison of the new device with the Predicate Device 6.0
The new control claims substantial equivalence to the Liquichek Urine Toxicology Control (K991558).
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Bio Rad
Liquichek™ Urine Toxicology
Control
(New Device) | Bio Rad
Liquichek™ Urine Toxicology
Control
(Predicate Device) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek™ Urine Toxicology
Control is intended for use as
quality control urine to monitor the
performance of laboratory urine
toxicology screening procedures. | Liquichek™ Urine Toxicology
Control is intended for use as
quality control urine to monitor the
performance of laboratory urine
toxicology screening procedures. |
| Levels | Same as predicate device. | Level S1= Drugs added at
concentrations
20-25% below
immunoassay cutoffs.
Level S2= Drugs added at
concentrations 20-25%
above immunoassay
cutoffs.
Level S3= Elevated immunoassay
Control. |
| Form | Liquid | Liquid |
| Matrix | Human urine | Human urine |
| Storage
(Unopened) | 2-8° C
until expiration date | 2-8° C
until expiration date |
| Open Vial
Claim | 2-8° C for 30 days. | 2-8° C for 30 days. |
| Differences | | |
| Analytes | Same analytes as the predicate
device with the additional claims | D-Amphetamine, Secobarbital,
Nordiazepam, 11-Nor-Δ-9-THC-9- |
| for Creatinine, pH and Specific
Gravity. | COOH, Benzoylecgonine, Ethanol,
Lysergic Acid Diethylamide (LSD),
Methadone, Methaqualone,
Nortriptyline, Morphine-(Free),
Phencyclidine, Propoxyphene. | |
06_SSE461_S1UrnTx
2
2.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Toxicology Control. Product claims are as follows:
- 2.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 2.2 Shelf Life: 24 months when stored at 2-8°C
Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
3
Image /page/3/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017
MAY 2 9 2002
Re: K021411
Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1, S2 and S3 Regulation Number: 21 CFR § 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I Product Code: DIF Dated: May 1, 2002 Received: May 3, 2002
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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
5
Ko2141 510 (k) Number (if known):_
Device Name:
Liquichek™ Urine Toxicology Control Levels S1, S2 and S3
Indications for Use:
A quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Alan Cooper
ision of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription use | |
| use | X |
| or | |
| Over-the Counter |