(27 days)
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
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. This product contains 0.1% sodium azide as a preservative.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4:
1. Table of Acceptance Criteria and Reported Device Performance
The submission form for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4 is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo acceptance criteria and proving performance against them in the same way a PMA submission might.
Therefore, the "acceptance criteria" for this device are largely implicit in its comparison to the predicate device and the demonstration of stability. The "reported device performance" primarily relates to its stability under various conditions.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Monitor performance of laboratory urine toxicology confirmatory procedures (same as predicate). | The device's intended use is identical to the predicate device. |
| Form Equivalence: Liquid form (same as predicate). | The device is provided in liquid form. |
| Matrix Equivalence: Human urine matrix (same as predicate). | The device is prepared from human urine. |
| Open Vial Stability: Stable for 30 days when stored tightly capped at 2-8°C. | Open vial stability: 30 days when stored at 2-8°C. |
| Shelf Life Stability: Stable for the declared shelf life when stored at 2-8°C. (Initial claim: 24 months). | Shelf life: 24 months when stored at 2-8°C. (Real-time studies ongoing). |
| Performance in Toxicology Confirmatory Procedures: Function effectively as a quality control for the listed analytes (implied by intended use and comparison to predicate). | The device includes the same analytes as the predicate, plus additional claims for Creatinine, pH, and Specific Gravity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies or provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Stability studies have been performed" and "All supporting data is retained on file at Bio-Rad Laboratories."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a quality control material like this, "ground truth" for stability would typically be established through analytical testing against known reference materials or validated methods, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used for diagnostic studies involving human interpretation or subjective assessments, which is not directly applicable to the stability testing of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for evaluating the impact of a device on human reader performance, which doesn't apply to a quality control material.
6. Standalone Performance Study
The focus of the submission is demonstrating substantial equivalence to a predicate device and proving the stability of the new device. The "performance" studies described are the stability studies. These are inherently standalone tests of the device's characteristics (e.g., concentration of analytes over time).
7. Type of Ground Truth Used
For the stability studies, the "ground truth" would be the analytical measurement of the analytes within the quality control material over time, compared to established reference values or specifications for stability. The document does not explicitly detail the methods used to establish these reference values, but it's implied to be internal analytical validation.
8. Sample Size for the Training Set
This product is a quality control material, not an algorithm or diagnostic model that requires a "training set" in the machine learning sense. Therefore, there is no training set mentioned or applicable for this device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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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.
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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.
| Characteristics | Bio Rad(New Device)Liquichek™ Urine ToxicologyControl | Bio Rad(New Device)Liquichek™ Urine ToxicologyControlPredicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek™ Urine ToxicologyControl is intended for use asquality control urine to monitor theperformance of laboratory urinetoxicology confirmatoryprocedures. | Liquichek™ Urine ToxicologyControl is intended for use asquality control urine to monitor theperformance of laboratory urinetoxicology confirmatoryprocedures. |
| Levels | Same as predicate device. | Level C1= Drugs added atConcentrationsapproximately 60%below confirmatorycutoffs or at LOQ.Level C2= Drugs added atconcentrations 20-25%below confirmatorycutoffs.Level C3= Drugs added atconcentrations aboveconfirmatory cutoffs. |
Table 1. Similarities and Differences between new and predicate device.
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| Level C4= Elevated confirmatorycontrol. | ||
|---|---|---|
| Form | Liquid | Liquid |
| Matrix | Human urine | Human urine |
| Storage(Unopened) | 2-8° Cuntil expiration date | 2-8° Cuntil expiration date |
| Open VialClaim | 2-8° C for 30 days. | 2-8° C for 30 days |
| Differences | ||
| Analytes | Same analytes as the predicatedevice with the additional claimsfor Creatinine, pH and SpecificGravity. | 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
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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 =
§ 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.