(27 days)
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No
The document describes a quality control material for laboratory procedures and does not mention any AI or ML components.
No
This device is a quality control urine used to monitor the performance of laboratory urine toxicology confirmatory procedures, not to treat any condition or ailment.
No
Explanation: This device is a quality control urine used to monitor the performance of laboratory urine toxicology confirmatory procedures. It is a control material, not a device that directly diagnoses a patient's condition.
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.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures." This clearly indicates it's used in vitro (outside the body) to assess the accuracy and reliability of diagnostic tests performed in a laboratory setting.
- Device Description: The description details its composition ("prepared from human urine with added constituents... drugs, drug metabolites...") and form ("liquid form"). This aligns with the nature of materials used in IVD quality control.
- Intended User / Care Setting: The intended user is a "laboratory," which is the typical setting for performing in vitro diagnostic tests and using quality control materials.
The fact that it's a quality control material for laboratory procedures is a strong indicator of its IVD classification. Quality control materials are essential components of the IVD ecosystem, ensuring the accuracy and reliability of diagnostic results.
N/A
Intended Use / Indications for Use
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
LiquichekTM Urine Toxicology Control Levels C1, C2, C3 and C4 is 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. This product contains 0.1% sodium azide as a preservative.
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
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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)
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:
- Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 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.
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.
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.
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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).
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§ 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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Summary of Safety and Effectiveness LiquichekTM Urine Toxicology Control Levels C1, C2, C3 and C4
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Ofelia Cachola Requlatory 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 C1, C2, C3 and C4
Common Name:
Drug Mixture Controls
Class I Classifications: 91DIF Product Code: 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: K981590
Description of Device 4.0
Liquichek™ Urine Toxicology Control Levels C1, C2, C3 and C4 is 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
This product contains 0.1% sodium azide as a preservative.
Statement of Intended Use 5.0
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Comparison of the new device with the Predicate Device 6.0
The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Control currently in commercial distribution (K981590). The new Liquichek™ Urine Toxicology Control has additional claims for Creatinine, pH, and Specific Gravity and the current product does not.
| Characteristi
cs | Bio Rad
(New Device)
Liquichek™ Urine Toxicology
Control | Bio Rad
(New Device)
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 confirmatory
procedures. | Liquichek™ Urine Toxicology
Control is intended for use as
quality control urine to monitor the
performance of laboratory urine
toxicology confirmatory
procedures. |
| Levels | Same as predicate device. | 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 above
confirmatory cutoffs. |
Table 1. Similarities and Differences between new and predicate device.
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| | | Level C4= Elevated confirmatory
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
for Creatinine, pH and Specific
Gravity. | D-Amphetamine,
d-Methamphetamine, Amobarbital,
Butalbital, Pentobarbital,
Phenobarbital, Secobarbital,
Alpha-Hydroxyalprazolam,
Nordiazepam,
Tetrahydrocannabinol (THC),
Benzoylecgonine, Ethanol,
Lysergic Acid Diethylamide (LSD),
Methadone, Methaqualone,
Codeine, Morphine-3-ß-D-
Glucuronide,
6-Monoacetylmorphine, |
7.0 Summary of Performance 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:
- Open vial: Once the control is opened, all analytes will be stable for 30 7.1 days when stored tightly capped at 2-8°C.
- Shelf Life: 24 months when stored at. 2-8°C. 7.2
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
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
Re: K021384
Trade/Device Name: Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4 Regulation Number: 21 CFR § 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I Product Code: DIF Dated: May 1, 2002 Received: May 2, 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.
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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 nredicate 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
510 (k) Number (if known): K02/384
Device Name:
Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4
Indications for Use:
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Sean Cooper
(Division Sign-Off)
on 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 or
Over-the Counter use =