(26 days)
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate are 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Liquichek™ Urine Toxicology Control:
This document is a Premarket Notification (510(k)) for a medical device (a quality control material), not an AI/ML powered device. Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of submission.
The "acceptance criteria" for this device are related to its stability and performance as a quality control material, ensuring it reliably monitors laboratory toxicology screening procedures. The "study" described is a stability study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2-8°C. | Stability studies have been performed and support this claim. "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. | Stability studies have been performed and support this claim. "24 months when stored at 2-8°C". (Note: The document states "Real time studies will be ongoing to support the shelf life," implying the 24-month claim is based on initial studies but will be further validated.) |
| Intended Use | To monitor the performance of laboratory urine toxicology screening procedures. | The device is intended for this use and is deemed substantially equivalent to a predicate device with the same intended use. The performance of the new device is considered comparable, and additional analytes (Creatinine, pH, Specific Gravity) are included, expanding its utility without altering the fundamental intended use or requiring a change in the primary performance monitoring ability. |
| Matrix | Human urine with added constituents (drugs, drug metabolites, preservatives, stabilizers). | The device is prepared from human urine with added constituents, matching the predicate device. Ensures suitability for toxicology screening. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" sample size in the context of individual urine samples for analysis because this is a quality control material itself, used to test other analytical devices.
- Sample Size for Stability Studies: Not explicitly stated as a number of replicates or batches. The document only mentions "Stability studies have been performed."
- Data Provenance: The studies were conducted by Bio-Rad Laboratories, the manufacturer. The data is retrospective in the sense that the studies were completed prior to the 510(k) submission, but the "real time studies will be ongoing" for shelf life suggest a prospective element to continuous monitoring of product stability. There is no mention of country of origin of the data in terms of patient samples, as it's a control material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a biochemical control material. Its "ground truth" (the expected concentration of analytes, its stability characteristics) is established through analytical chemistry methods during formulation and stability testing, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method in the traditional sense (e.g., for clinical diagnoses) for a quality control product. The "truth" of its composition and stability is determined by standardized laboratory methods and analytical instrumentation.
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/ML device, nor is it a diagnostic tool where human readers would be involved in interpreting results in the context of aiding human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or an AI device. It's a laboratory reagent/control.
7. The Type of Ground Truth Used
The ground truth for the composition of the Liquichek™ Urine Toxicology Control (i.e., the presence and concentration of analytes) is established through analytical chemistry methods and formulation specifications. For stability, the ground truth is determined by measuring analyte concentrations over time under specified storage conditions using validated analytical methods. This is essentially a form of analytical or laboratory-determined truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
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Bio-Rad Laboratories Premarket Notification Section 510(k) Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opia Summary of Safety and Effectiveness
Page 1 of 3
Summary of Safety and Effectiveness Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: Fax: (949) 598-1555
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 S1 LowOpiate and S2 Low Opiate |
|---|---|
| Common Name: | Drug Mixture Controls |
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek 100 Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Numbers: K992812 and K992809
4.0 Description of Device
Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate are 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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Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Summary of Safety and Effectiveness
Statement of Intended Use 4.
ﺍ
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Comparison of the new device with the Predicate Device 5.0
The new Liquichek™ Urine Toxicology Control claims substantial equivalence to the Liquichek™ Urine Toxicology Control currently in commercial distribution (K992812 and K992809). The new Liquichek™ Urine Toxicology Control has additional claims for Creatinine, pH, and Specific Gravity and the current product does not.
| Characteristics | Bio RadLiquichek™ Urine ToxicologyControl(New Device) | Bio RadLiquichek™ Urine ToxicologyControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek™ Urine ToxicologyControl is intended for use asquality control urine to monitor theperformance of laboratory urinetoxicology screening procedures. | Liquichek™ Urine ToxicologyControl is intended for use as aquality control urine to monitor theperformance of laboratory urinetoxicology screening procedures. |
| Levels | Same as predicate device. | Level S1Low Opiate = Drugsadded at concentrations20-25% below immunoassaycutoffs.Level S2 Low Opiate = Drugsadded at concentrations20-25% above immunoassaycutoffs. |
| Form | Liquid | Liquid |
| Matrix | Human urine | Human urine |
| Storage(Unopened) | 2-8° Cuntil expiration date | 2-8° Cuntil expiration date |
| Open Vial Claim | 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 Specific | D-Amphetamine, Secobarbital,Nordiazepam, 11-Nor-Δ-9-THC-9-COOH), Benzoylecgonine. |
Table 1. Similarities and Differences between new and predicate device.
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Bio-Rad Laboratories
Premarket Notification Section 510(k) for Liquichek Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate
Summary of Safety and Effectiveness
| Gravity. | Ethanol, Lysergic Acid Diethylamide (LSD), Methadone, Methaqualone, Morphine (Free), |
|---|---|
| ---------- | ---------------------------------------------------------------------------------------- |
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:
Phencyclidine, Propoxyphene,
Nortriptyline.
- 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: 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.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 9 2002
Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017
K021414 Re:
Trade/Device Name: Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate Regulation Number: 21 CFR § 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I Product Code: DIF Dated: May 1, 2002 Received: May 3, 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 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 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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021414 510 (k) Number (if known):
Device Name:
Liquichek™ Urine Toxicology Control Levels S1 Low Opiate and S2 Low Opiate
Indications for Use:
A quality control urine to monitor the performance of laboratory urine toxicology screening procedures.
Sean Cooper
(Division Sign-Off)
Division 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
§ 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.