(26 days)
Liquichek™ Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Liquichek 14 Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate 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.
The provided text describes a 510(k) premarket notification for a medical device, the Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate. This type of notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria in the same way a novel device might.
Therefore, the document does not contain the typical information one would expect for acceptance criteria of a diagnostic algorithm or AI system, nor does it describe a study proving the device meets such criteria with respect to diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, the "acceptance criteria" for this device relate to its intended use as a quality control material and its stability, demonstrating that it performs similarly to the predicate device.
Here's an analysis of the provided text based on your request, interpreting "acceptance criteria" in the context of a quality control product:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding performance data for diagnostic accuracy. Instead, the performance data focuses on stability, which is a key characteristic for a quality control material.
| Characteristic | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Maintain stability for analytes for a defined period after opening. | 30 days when stored tightly capped at 2-8°C. |
| Shelf Life | Maintain stability for analytes for a defined period when unopened. | 24 months when stored at 2-8°C. |
| Intended Use | Function as a quality control urine to monitor laboratory urine toxicology confirmatory procedures. | Stated as the intended use, and substantial equivalence to a predicate device with the same intended use is claimed. No performance metrics for this are provided, except by reference to the predicate. |
| Matrix | Human urine with added constituents, similar to predicate. | Human urine, same as predicate. |
| Form | Liquid, similar to predicate. | Liquid, same as predicate. |
| Storage (Unopened) | 2-8°C, similar to predicate. | 2-8°C until expiration date, same as predicate. |
| Storage (Open Vial) | 2-8°C for 30 days, similar to predicate. | 2-8°C for 30 days, same as predicate. |
| Analytes | Contain specific analytes, including "Low Opiate" levels, and additional claims for Creatinine, pH, and Specific Gravity. | Contains specified analytes at C2 Low Opiate (20-25% below cutoff) and C3 Low Opiate (20-25% above cutoff) levels, plus Creatinine, pH, and Specific Gravity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Stability studies" were performed. However, it does not provide:
- The sample size (e.g., number of vials, number of measurements).
- The data provenance (country of origin).
- Whether the studies were retrospective or prospective, although "Real time studies will be ongoing" suggests prospective data collection for shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this document. The device is a quality control material, not a diagnostic algorithm that requires expert ground truth for imaging or other diagnostic interpretations. Its "performance" is about its chemical stability and concentration levels, which are determined by laboratory means, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used to establish ground truth in diagnostic studies, particularly when multiple experts are involved. For chemical stability testing of a quality control product, laboratory methods and instrument readings determine the results.
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
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, typically in reading medical images or complex diagnostic data. This device is a quality control material and does not involve human "readers" interacting with an AI system for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device relates to the known concentration of analytes within the control material and its stability over time. This is established through internal laboratory testing and analytical chemistry methods, where the concentrations are intentionally set and then verified. It's not based on expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
This information is not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI algorithms. The product's composition and stability are determined through manufacturing processes and analytical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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K02/415
Summary of Safety and Effectiveness
MAY 2 9 2002
Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: Fax: (949) 598-1555
Contact Person
Ofelia Cachola Regulatory 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 C2 LowOpiate and C3 Low Opiate |
|---|---|
| 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™ Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K981590
4.0 Description of Device
Liquichek 14 Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate 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 has additional claims for Creatinine, pH and Specific Gravity and the current product does not.
| Characteristics | Bio Rad(New Device)Liquichek™ Urine ToxicologyControl, Levels C2 Low Opiateand C3 Low Opiate | Bio Rad(New Device)Liquichek™ Urine ToxicologyControl Levels C2 and C3Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek™ Urine ToxicologyControl is intended for use asquality control urine to monitorthe performance of laboratoryurine toxicology confirmatoryprocedures. | Liquichek™ Urine ToxicologyControl is intended for use asquality control urine to monitor theperformance of laboratory urinetoxicology confirmatoryprocedures. |
| Form | Liquid | Liquid |
| Matrix | Human urine | Human urine |
| Storage(Unopened) | 2-8° Cuntil expiration date | 2-8° Cuntil expiration date |
| Open Vial | 2-8° C for 30 days. | 2-8° C for 30 days |
| Claim | ||
| Differences | ||
| Levels | Level C2 Low Opiate = Drugsadded at concentrations 20-25%below confirmatory cutoffs. (Foruse with 300 ng/ml opiate cutoff) | Level C2= Drugs added atconcentrations 20-25% belowconfirmatory cutoffs.Level C3= Drugs added at 20-25% |
Table 1. Similarities and Differences between new and predicate device.
08_SSEUrnTX_C2LowOp
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| Level C3 Low Opiate = Drugsadded at 20-25% concentrationsabove confirmatory cutoffs. (Foruse with 300 ng/mL opiatecutoff). | concentrations above confirmatorycutoffs. | |
|---|---|---|
| Analytes | Same analytes as the predicatedevice with the additional claimsfor Specimen Validity criteria: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,Phencyclidine and Propoxyphene. |
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 Product claims are as follows:
- 7.1 Open vial: Once the control is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- 7.2 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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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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
K021415 Re:
Trade/Device Name: Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 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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510 (k) Number (if known): K 6214/5
Device Name:
Liquichek™ Urine Toxicology Control Levels C2 Low Opiate and C3 Low Opiate
Indications for Use:
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K021415
(Please Do NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
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.