(47 days)
Not Found
No
The document describes a quality control material for laboratory toxicology screening and does not mention any AI or ML components.
No
Explanation: This device is a quality control for laboratory urine toxicology screening procedures, not a treatment or diagnostic tool for patients. It is used to monitor the performance of tests, not for direct therapeutic use.
No
Explanation: This device is a quality control material used to monitor the performance of toxicology screening procedures, not to diagnose a condition in a patient.
No
The device description clearly states the control is prepared from human urine with added substances and is provided in liquid form, indicating a physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is "intended for use as quality controls urine to monitor the performance of laboratory urine toxicology screening procedures." This indicates that the product is used in vitro (outside the body) to analyze a biological sample (urine) for diagnostic purposes (monitoring the performance of toxicology screening).
- Device Description: The description confirms it's a prepared control material from human urine with added substances, designed for laboratory use.
- Intended User / Care Setting: It is intended for use in a "laboratory," which is a typical setting for IVD testing.
While the document doesn't explicitly use the term "IVD," the intended use and nature of the product align perfectly with the definition of an In Vitro Diagnostic device. It's a reagent/material used in a laboratory setting to assess the performance of a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Liquichek Urine Toxicology Controls are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology screening* procedures. *[S1E/S2E: enzyme immunoassay (EIA)]
Product codes
DIF
Device Description
Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (Screen Series). Product claims are as follows:
- Open vial: All analytes are stable for 30 days when stored tightly capped at 2-8°C.
- Shelf Life:
- S1E, S2E, S1E Low Opiate, S2E Low Opiate: Two years stored at 2-8 °C
- S1, S2, S3, S1 Low Opiate, S2 Low Opiate: Three years 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)
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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 Liquichek Urine Toxicology Control (Screen Series)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
December 16, 2003
2.0 Device Identification
Product Trade Name:
Liquichek Urine Toxicology Control (Screen Series)
- 0 Liquichek Urine Toxicology S1 Control
- Liquichek Urine Toxicology S2 Control ப
- Liquichek Urine Toxicology S3 Control 0
- 0 Liquichek Urine Toxicology S1 Low Opiate Control
- Liquichek Urine Toxicology S2 Low Opiate Control 0
- 0 Liquichek Urine Toxicology S1E Control
- Liquichek Urine Toxicology S2E Control
- 0 Liquichek Urine Toxicology S1E Low Opiate Control
- 0 Liquichek Urine Toxicology S2E Low Opiate Control
| Common Name: | Drug Mixture Control |
|---|---|
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K021411
4.0 Description of Device
Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
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5.0 Statement of Intended Use
Liquichek Urine Toxicology Controls are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology screening* procedures. *[S1E/S2E: enzyme immunoassay (EIA)]
6.0 Comparison of the new device with the Predicate Device
The new Liquichek Urine Toxicology Controls claim substantial equivalence to the Liquichek Urine Toxicology Controls currently in commercial distribution (K021411).
| Characteristics | Bio-Rad Liquichek Urine Toxicology Control
(Screen Series)
(New Device) | Bio-Rad Liquichek Urine Toxicology Control
(Screen Series)
(Predicate Device K021411) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| 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. | Liquichek Urine Toxicology Control is intended for use
as a quality control urine to monitor the performance
of laboratory urine toxicology screening procedures. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage
(Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| Open Vial | 30 days at 2-8°C | 30 days at 2-8°C |
| Drugs | Same as the predicate device | 11-Nor-Δ-9-THC-9-COOH, Amphetamines, d-Amphetamine, Barbiturates, Benzodiazepines, Benzoylecgonine, Cannabinoids, Cocaine, Ethanol, Lysergic Acid Diethylamide (LSD), Methadone, Methaqualone, Morphine (Free), Nordiazepam, Nortriptyline, Opiates, Phencyclidine, Propoxyphene, Secobarbital, Tricyclic Antidepressants |
| Differences | | |
| Levels | S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 Low
Opiate. Includes new levels added to the product
line: S1E Low Opiate and S2E Low Opiate | S1, S2, S3, S1E, S2E, S1 Low Opiate and S2 Low
Opiate. Does not include levels:
S1E Low Opiate and S2E Low Opiate |
| Preservatives &
Label Warnings | Antibiotic Preservative cocktail | Contains 0.1% Sodium Azide
Requires hazard symbols |
Table 1. Similarities and Differences between new and predicate device.
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 (Screen Series). Product claims are as follows:
- Open vial: All analytes are stable for 30 days when stored tightly capped at 2-8°C. 7.1
- 7.2 Shelf Life:
- ם S1E, S2E, S1E Low Opiate, S2E Low Opiate: Two years stored at 2-8 °C ם S1, S2, S3, S1 Low Opiate, S2 Low Opiate: Three years stored at 2-8 °C
- 7.3 Real time studies will be ongoing to support the shelf life of this product.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 3 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K033924
Trade/Device Name: Liquichek Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: December 16, 2003 Received: December 18, 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
KO33924 510 (k) Number (if known):
Device Name:
Liquichek Urine Toxicology Control
- Liquichek Urine Toxicology S1 Control 0
- Liquichek Urine Toxicology S2 Control 0
- Liquichek Urine Toxicology S3 Control 0
- Liquichek Urine Toxicology S1 Low Opiate Control ប្រ
- Liquichek Urine Toxicology S2 Low Opiate Control D
- Liquichek Urine Toxicology S1E Control ロ
- Liquichek Urine Toxicology S2E Control
- Liquichek Urine Toxicology S1E Low Opiate Control 0
- ロ Liquichek Urine Toxicology S2E Low Opiate Control
Indications for Use:
Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Levels S1E, S2E, S1E Low Opiate and S2E Low Opiate
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.
Aberto Salm
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use or
Over-the Counter use