(11 days)
Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.
Liquichek Qualitative Urine Toxicology Controls are 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.
Here's an analysis of the provided information, structured to address your specific requests.
This document describes a quality control product, not an AI/ML medical device. Therefore, several of the requested sections (e.g., MRMC studies, standalone algorithm performance, AI assistance) are not applicable.
Acceptance Criteria and Study for Liquichek Qualitative Urine Toxicology Control (K052053)
This submission is for a quality control material rather than a diagnostic device that performs analysis. As such, the "acceptance criteria" and "device performance" relate to the stability and composition of the control material itself, ensuring it functions as intended for monitoring laboratory procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | All analytes stable for 30 days when stored tightly capped at 2-8°C or 18-25°C. | The statement directly claims: "All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C or 18 to 25°C." This indicates the device met this performance claim based on internal studies. |
| Shelf Life | All analytes stable for 3 years at 2-8°C. | The statement directly claims: "3 Years at 2 to 8°C." This indicates the device met this performance claim based on initial studies, with real-time studies ongoing. |
| Traceability/Ground Truth | The control material contains specified drugs of abuse and metabolites at known concentrations to act as a positive or negative control. The Reported Device Performance refers to the characteristics of the formulated control material, which itself serves as a "ground truth" for the assays it monitors. | The control is "prepared from human urine with added drugs of abuse and metabolites...". The new device adds Oxycodone to the existing panel of drugs (Amphetamines, Barbiturates, Benzodiazepines, Benzoylecgonine, Cannabinoids, Cocaine, d-Amphetamine, d-Methamphetamine, Ethanol, LSD, MDMA, Methadone, Methaqualone, Morphine (Free), Nordiazepam, Nortriptyline, Opiates, Oxazepam, Phencyclidine, Propoxyphene, Secobarbital, Tricyclic Antidepressants (TCA)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The studies referenced are stability studies of the physical control product itself, not diagnostic tests on patient samples. The "test set" would refer to control vials tested over time and under various conditions.
- Data Provenance: The studies were "performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control." This indicates prospective, internal testing conducted by Bio-Rad Laboratories. The country of origin is implied to be within the US, given Bio-Rad's address in California.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a quality control material, not a diagnostic or AI device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its precisely manufactured composition and stability characteristics, determined by chemical analysis and stability protocols.
4. Adjudication Method for the Test Set
This is not applicable for a quality control material stability study. Adjudication methods are typically used when human interpretation of data (e.g., medical images, clinical findings) is involved in establishing ground truth or comparing performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable as the device is a quality control material, not an AI/ML diagnostic system or a system that aids human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this product is its manufactured composition and confirmed stability characteristics. The control material itself is formulated to contain specific analytes (drugs of abuse and their metabolites) at known concentrations. The stability studies (shelf life and open vial) then confirm that these known concentrations remain stable under storage conditions, ensuring the integrity of the "ground truth" over time.
8. The Sample Size for the Training Set
This is not applicable. Quality control materials do not typically have "training sets" in the context of machine learning or diagnostic algorithm development. The "design and formulation" of the control material is based on chemical and manufacturing principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as above. The composition of the control material is established during its manufacturing process using validated analytical methods to ensure the concentrations of added substances are accurate.
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Summary of Safety and Effectiveness Liquichek Qualitative Urine Toxicology Control
1.0 Submitter
AUG 9 - 2005
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist (949) 598-1467 Telephone:
Date of Summary Preparation
July 25, 2005
Device Identification 2.0
| Product Trade Name: | Liquichek Qualitative Urine Toxicology Control |
|---|---|
| Common Name: | Drug Mixture Control Materials |
| Classifications: | Class I |
| Product Code: | DIF |
21 CFR 862.3280 Regulation Number:
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Qualitative Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K033366
4.0 Description of Device
Liquichek Qualitative Urine Toxicology Controls are 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.
5.0 Statement of Intended Use
Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.
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Comparison of the new device with the Predicate Device 6.0
The new Liquichek Qualitative Urine Toxicology Control contains Oxycodone, and the rre new Equilonek Qualitative Urine Toxicology Control (K033366) to which substantial equivalence is claimed, does not contain Oxycodone.
| Bio-Rad Liquichek QualitativeUrine Toxicology Control(New Device) | Bio-Rad Liquichek QualitativeUrine Toxicology Control(Predicate Device K001973) | |
|---|---|---|
| Characteristics | ||
| Similarities | ||
| Intended Use | Liquichek Qualitative Urine Toxicology Control isintended for use as an assayed quality control urine tomonitor the performance of laboratory procedures forqualitative urine toxicology. | Liquichek Qualitative Urine Toxicology Control isintended for use as an assayed quality control urineto monitor the performance of laboratory proceduresfor qualitative urine toxicology. |
| 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 to 8°C or 18 to 25°C | 30 days at 2 to 8°C or 18 to 25°C |
| Differences | ||
| Drugs | Same as the predicate device with addition of Oxycodone | Contain:AmphetaminesBarbituratesBenzodiazepinesBenzoylecgonineCannabinoidsCocained-Amphetamined-MethamphetamineEthanolLSDMDMA (Ecstasy)MethadoneMethaqualoneMorphine (Free)NordiazepamNortriptylineOpiatesOxazepamPhencyclidinePropoxypheneSecobarbitalTricyclic Antidepressants (TCA) |
| Do not contain:Oxycodone |
Table 1. Similarities and Differences between new and predicate device.
2.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control. Product claims are as follows:
- 2.1 Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8°C or 18 to 25°C.
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2.2 Shelf Life: 3 Years at 2 to 8°C
- 2.3 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 - 2005
Ms. Suzanne S. Parsons Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
K052053 Re:
K032035
Trade/Device Name: Liquichek Qualitative Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology control material Regulatory Class: Class I Product Code: DIF Dated: July 25, 2005 Received: July 29, 2005
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the idevice We have reviewed your Section 910(x) premained institution marketed in interstate referenced above and have uctchillied the devices noredicate devices marketed in interstate for use stated in the encrosury manative power manatical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 28, 1970, the charters and other of the Federal Food. Drug, devices that have been reclassified in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the A and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The Y ou may, inerelore, market the device, salgoer to inements for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the fice labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into effici vitas major regulations affecting your device it may be subject to such additional controllar Ensing mix can be found in Title 21, Coue of I ederal rogging your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buccession with other requirements of the Act
that FDA has made a determination that your device complies with on your must that FDA has made a decemmanon and Jour Secreed by other Federal agencies. You must or any Federal statutes and regulations administer of the registration and listing (21 comply with an the Act 3 requirements intractly good manufacturing practice CFK Part 807), labeling (21 OF Releves (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your avence of your device of your device to a legally
premarket notification. The FDA finding of substantial equivale vour premarked notification. The PDA Intaing of basistication 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 about the up from device, please contact the Office of In
or questions on the promotion and advertising of your a takes and the mass not th of questions on the promotion and Safety at (301) 594-3084. Also, please note the Vitto Diagnostic Device Livananon and Sareer at (3) and Sales (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notifications the regulation entitled, "Misoranting by reicrenes we presponsibilities under the Act from the You may outain buller general mormations. Jour 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,
Albert Benson, M.A.
Acting 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):
y
Device Name:
Liquichek Qualitative Urine Toxicology Control
Indications For Use:
Liquichek Qualitative Urine Toxicology Control is intended for use Liquicher Quality control urine to monitor the performance of as an accry procedures for qualitative urine toxicology.
Prescription Use_ X (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)
PAC
vision Sign-Off) Sion of Clinical Laboratory Devices 510(k) Number
Page 1 of
§ 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.