(35 days)
Not Found
No
The document describes a quality control material for laboratory testing and does not mention any computational or analytical capabilities that would involve AI or ML.
No
This device is a quality control material intended to monitor the precision of laboratory urine toxicology screening procedures, not to treat or diagnose patients.
No.
This device is described as a "quality control urine to monitor the precision of laboratory urine toxicology screening procedures," indicating it is used to assess the performance of diagnostic tests, not to diagnose a condition itself.
No
The device description clearly states the control is prepared from human urine with added substances and is provided in liquid form, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "monitoring the precision of laboratory urine toxicology screening procedures." This indicates it is used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description confirms it is a "quality control urine" prepared from human urine with added substances. This is a typical characteristic of an IVD control material.
- Care Setting: The intended user is described as performing "laboratory urine toxicology screening procedures," which are diagnostic tests performed in a laboratory setting.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening procedures.
Product codes
DIF
Device Description
Liguichek 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Stability studies have been performed for Liquichek Urine Toxicology control to determine Stabliky otation have belf life claims. Product claims. Product claims are as follows:
7.1 Open Vial: 30 days at 2 to 8°C.
7.2 Closed Vial (Thawed): 45 days at 2 to 8°C.
7.3 Shelf Life Stability 2 Years at -20°C to -70°C
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Summary of Safety and Effectiveness Liquichek Urine Toxicology Control
MAR 2 7 2012
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
February 16th, 2012
·2.0 Device Identification
Product Trade Name:
Liquichek Urine Toxicology Control
Liquichek Urine Toxicology Control Level S10
- Liquichek Urine Toxicology Control Level S20
- Liquichek Urine Toxicology Control Level S10 Low Opiate
- Liquichek Urine Toxicology Control Level S2O Low Opiate
| Common Name: | Drug Mixture Control Materials |
|---|---|
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Urine Toxicology Control (Screen Series) Bio-Rad Laboratories Irvine, California
510 (k) Number: K033924
4.0 Description of Device
Liguichek 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 Intended Use
Liguichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening procedures.
1
Comparison of the new device with the Predicate Device 6.0
Liquichek Urine Toxicology Control claims substantial equivalence to the Liquichek Urine Toxicology Control (Screen Series) currently in commercial distribution (K033924). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Urine Toxicology Control
(New Device) | Liquichek Urine Toxicology Control
(Screen Series)
(Predicate Device, K033924) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Liquichek Urine Toxicology Control is
intended for use as a quality control urine
to monitor the precision of
laboratory urine toxicology screening
procedures. | Liquichek Urine Toxicology Control is
intended for use as a quality control urine
to monitor the performance of laboratory
urine toxicology screening procedures. |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Open Vial Stability | 30 days at 2°C to 8 °C | 30 days at 2°C to 8 °C |
| Table 1. Similarities and Differences between new and predicate device. | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Differences | ||
|---|---|---|
| Storage unopened (Shelf Life) | -20 to -70°C until expiration date | 2 to 8°C until expiration date |
| Closed Vial (Thawed) Stability | 45 days at 2°C to 8 °C | No Claim |
| Levels | Level S1O, S2O, S1O Low Opiate, S2O | |
| Low Opiate | Levels S1, S2, S3, S1 Low Opiate and | |
| S2 Low Opiate | ||
| Analytes | Contains: | |
| 11-Nor-Δ-9-THC-9-COOH | ||
| Benzoylecgonine | ||
| Ethanol | ||
| Lysergic Acid Diethylamide (LSD) | ||
| Methadone | ||
| Methaqualone | ||
| Morphine (Free) | ||
| Oxazepam | ||
| Phencyclidine (PCP) | ||
| Propoxyphene | ||
| Secobarbital | ||
| d-Methamphetamine | ||
| Does not contain: | ||
| Nordiazepam | ||
| Nortriptyline | ||
| d-Amphetamine | Contains: | |
| 11-Nor-Δ-9-THC-9-COOH | ||
| Benzoylecgonine | ||
| Ethanol | ||
| Lysergic Acid Diethylamide (LSD) | ||
| Methadone | ||
| Methaqualone | ||
| Morphine (Free) | ||
| Nordiazepam | ||
| Nortriptyline | ||
| Phencyclidine (PCP) | ||
| Propoxyphene | ||
| Secobarbital | ||
| d-Amphetamine | ||
| Does not contain: | ||
| d-Methamphetamine | ||
| Oxazepam |
.
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7.0 Statement of Supporting Data
Stability studies have been performed for Liquichek Urine Toxicology control to determine Stabliky otation have belf life claims. Product claims. Product claims are as follows:
| 7.1 Open Vial: | 30 days at 2 to 8°C. | |
|---|---|---|
| 7.2 Closed Vial (Thawed): | 45 days at 2 to 8°C. | |
| 7.3 Shelf Life Stability | 2 Years at -20°C to -70°C |
3
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Bio-Rad Laboratories, QSD Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance 9500 Jeronimo Road Irvine, CA 92618-2017
MAR 2 7 2012
K120504 Re:
Trade/Device Name: Liquichek Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I (Reserved) Product Code: DIF Dated: February 17, 2012 Received: February 21, 2012
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 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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.
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The figure is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known):
Device Name:
Liquichek Urine Toxicology Control
- · Liquichek Urine Toxicology Control Level S10
- Liquichek Urine Toxicology Control Level S2O
- Liquichek Urine Toxicology Control Level S10 Low Opiate .
- Liquichek Urine Toxicology Contro! Level S2O Low Opiate .
Indications for Use:
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening 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)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K120504
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