(44 days)
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 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.
The provided document is a 510(k) premarket notification for a quality control device, not a diagnostic device with performance metrics typically found in clinical studies. Therefore, many of the requested fields are not applicable.
Here's the breakdown of the information that can be extracted and explanations for what isn't applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Monitor the performance of laboratory urine toxicology confirmatory procedures (same as predicate). | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. (Matches predicate) |
| Form | Liquid (same as predicate). | Liquid (Matches predicate) |
| Matrix | Urine (same as predicate). | Urine (Matches predicate) |
| Storage | 2-8°C until expiration date (same as predicate). | 2-8°C until expiration date (Matches predicate) |
| Open Vial | 30 days at 2-8°C (same as predicate). | 30 days at 2-8°C |
| Drugs | Contains drugs consistent with monitoring urine toxicology confirmatory procedures (similar to predicate, with additions). | Contains all drugs present in the predicate device (d-Amphetamine, d-Methamphetamine, Secobarbital, Amobarbital, Butalbital, Pentobarbital, Phenobarbital, Nordiazepam, α-hydroxyalprazolam, 11-Nor-Δ-9-THC-9-COOH, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-D-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, Specific Gravity, pH) Additionally, contains: MDMA, MDA, MDEA |
| Shelf Life | Not explicitly stated as acceptance criteria, but stability studies support a shelf life of 3 years at 2-8°C for the predicate. | Three years stored at 2-8°C (Supported by stability studies). Real-time studies are ongoing. |
Explanation of Device Performance: The "device performance" for this quality control material is its ability to remain stable and effectively serve its intended purpose (monitoring the performance of toxicology tests) over specified periods. The data presented primarily addresses stability.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document describes a quality control product, not a diagnostic test evaluated on human samples. The "studies" were stability studies on the product itself.
- Data Provenance: The stability studies were conducted by Bio-Rad Laboratories. The provenance of the human urine used for manufacturing the control is not specified, but the "data" itself relates to the control product's stability. Both open vial and shelf life studies were performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of disease status or clinical outcome, is not relevant for a quality control material.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication. The performance data is based on stability testing of the control material.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-powered diagnostic device, and no human reader studies were conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical quality control material, not an algorithm.
7. The type of ground truth used
- Not applicable in the conventional sense of a clinical ground truth. The "ground truth" for this device revolves around its chemical composition and stability specifications, which are determined during manufacturing and validated through analytical testing.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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APR 2 9 2005
Page 1 of 2
Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Level C1)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
March 9, 2005
2.0 Device Identification
Product Trade Name:
Liquichek Urine Toxicology Control
| Common Name: | Drug Mixture Control |
|---|---|
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
Device to Which Substantial Equivalence is Claimed 3.0
Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K033404
4.0 Description of Device
Liquichek Urine Toxicology Control is 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.
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.
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Comparison of the new device with the Predicate Device 6.0
The new Liquichek Urine Toxicology Control (Level C1) claims substantial equivalence The now Eiquichek Urine Toxicology Control (Level C1) currently in commercial distribution (K033404). The new Liquichek Urine Toxicology Control contains MDMA, MDA and MDEA and the predicate device does not.
| Characteristics | Bio-Rad Liquichek Urine Toxicology Control(Level C1)(Predicate Device K033404) | Bio-Rad Liquichek Urine Toxicology Control(Level C1)(New 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. |
| 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 |
| Differences | ||
| Drugs | Contains:d-Amphetamined-MethamphetamineSecobarbitalAmobarbitalButalbitalPentobarbitalPhenobarbitalNordiazepama-hydroxyalprazolam11-Nor-Δ-9-THC-9-COOHBenzoylecgonineEthanolLSDMethadoneMethaqualoneMorphine-3-β-D-glucuronideCodeinePhencyclidineNorpropoxypheneCreatinineSpecific GravitypHDoes not contain:MDMAMDA | Contains:d-Amphetamined-MethamphetamineSecobarbitalAmobarbitalButalbitalPentobarbitalPhenobarbitalNordiazepamα -hydroxyalprazolam11-Nor-Δ-9-THC-9-COOHBenzoylecgonineEthanolLSDMethadoneMethaqualoneMorphine-3-β-D-glucuronideCodeinePhencyclidineNorpropoxypheneCreatinineSpecific GravitypHMDMAMDAMDEA |
| Table 1. Similarities and Differences between new and predicate device. | |
|---|---|
Summary of Performance Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urine Toxicology Control (Level C1). Product claims are as follows:
- 30 days at 2-8°C. 7.1 Open vial:
- Three years stored at 2-8°C 7.2 Shelf Life:
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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 2005
Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine CA 92618-2017
K050682 Re:
Trade/Device Name: Liquichek Urine Toxicology Control ( Level C1) Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: March 10, 2005 Received: March 16, 2005
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 for ass sured in the 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 r rease of acress a determination that your device complies with other requirements of the Act that 1197 has 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 (QS) 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) I his letter will anow you to ough finding of substantial equivalence of your device to a legally premarket notification - The sults 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, If you desire specific information actuatising of your device, please contact the Office of In or questions on the promotion and Safety at (240)276-0484. 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 I bu may other belief general mensactional 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean 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
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Indications for Use
510(k) Number (if known):
| Device Name: | Liquichek Urine Toxicology Control (Level C1) |
|---|---|
| Indications For Use: | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert Ca
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050682
§ 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.