(8 days)
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No
The document describes a quality control material for laboratory urine toxicology screening and does not mention any AI or ML components in its description, intended use, or performance studies.
No
This device is a quality control material used to monitor the performance of laboratory toxicology screening procedures, not to treat or diagnose a disease.
No
Explanation: This device is a quality control material used to monitor the performance of laboratory urine toxicology screening procedures. It is not used to diagnose a patient's condition.
No
The device is a liquid quality control material for laboratory testing, not a software application.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures." This clearly indicates it is used in vitro (outside the body) to analyze a biological sample (urine) for diagnostic purposes (monitoring the performance of a toxicology screening procedure).
- Device Description: The description confirms it is prepared from human urine with added constituents, further supporting its use as a control material for laboratory testing.
- Intended User / Care Setting: The intended user is a "laboratory," which is the typical setting for IVD testing.
The other sections, while providing useful information about the device, do not contradict its classification as an IVD. The lack of image processing, AI/ML, specific anatomical sites, or patient age ranges is consistent with a quality control material used in a laboratory setting.
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 enzyme immunoassay (EIA) screening procedures.
Product codes (comma separated list FDA assigned to the subject device)
91DIF
Device Description
Liquichek™ Urine Toxicology Control Levels S1E and S2E 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.
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: 2 years when stored unopened 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.)
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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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Page 1 of 3
Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1E and S2E
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Elizabeth Platt RA/QA Manager Telephone: (949) 598-1285
Date of Summary Preparation
August 2, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Urine Toxicology Control Levels S1E and
S2E |
|---------------------|-----------------------------------------------------------|
| Common Name: | Drug Mixture Controls |
| Classifications: | Class I |
| Product Code: | 91DIF |
| Regulation Number: | CFR 862.3280 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek 1M Urine Toxicology Control Levels S1 and S2 Bio-Rad Laboratories Irvine, California
Docket Numbers: K991558
4.0 Description of Device
Liquichek™ Urine Toxicology Control Levels S1E and S2E 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.
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Statement of Intended Use 5.0
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
- 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.
6.0 Comparison of the new device with the Predicate Device
The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Controls currently in commercial distribution (K991558).
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Bio Rad
Liquichek™ Urine Toxicology Control,
Levels S1E and S2E
(New Device) | Bio Rad
Liquichek™ Urine Toxicology Control,
Levels S1 ans S2
(Predicate Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| 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 | | |
| Intended Use | A quality control urine to monitor the
performance of laboratory urine
toxicology enzyme immunoassay
(EIA) screening procedures. | A quality control urine to monitor the
performance of laboratory urine
toxicology screening procedures. |
| Levels | Level S1E = Drugs and drug
metabolites added during
manufacture at concentrations
20-25% below enzyme
immunoassay cutoff levels.
Level S2E = Drugs and drug
metabolites added at concentrations
20-25% above enzyme
immunoassay cutoff levels. | Level S1 = Drugs and drug
metabolites added at concentrations
20-25% below immunoassay cutoff
levels.
Level S2 = Drugs and drug
metabolites added at concentrations
20-25% above immunoassay cutoff
levels. |
2
| Characteristics | Bio Rad
Liquichek™ Urine Toxicology Control,
Levels S1E and S2E
(New Device) | Bio Rad
Liquichek™ Urine Toxicology Control,
Levels S1 and S2
(Predicate Device) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Claimed
Analytes | Methamphetamine, Secobarbital,
Lormetazepam, Tetrahydrocannabinol
(THC), Benzoylecgonine, Ethanol,
Lysergic Acid Diethylamide (LSD),
Methadone, Methaqualone, Morphine
(Free), Phencyclidine, Propoxyphene,
Nortriptyline and addition of Creatinine,
pH, Specific Gravity. | Amphetamine, Secobarbital,
Nordiazepam, Tetrahydrocannabinol
(THC), Benzoylecgonine, Ethanol,
Lysergic Acid Diethylamide (LSD),
Methadone, Methaqualone, Morphine
(Free), Phencyclidine, Propoxyphene,
Nortriptyline. |
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: 2 years when stored unopened 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.
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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 eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
AUG 2 2 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K022707
Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: August 2, 2002 Received: August 14, 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. Iisting 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 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 Butman
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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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek™ Urine Toxicology Control Levels S1E and S2E
Indications for Use:
Liquichek™ Urine Toxicology Control Levels S1E and S2E is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use Over-the Counter or use
Carol C. Benson (for Jean Cooper, DUm