(44 days)
Not Found
No
The document describes a quality control material for laboratory toxicology testing and does not mention any AI or ML components.
No
This device is a quality control material used to monitor the performance of laboratory toxicology tests, not to treat a medical condition.
No
The device is a quality control material used to monitor the performance of laboratory toxicology confirmatory procedures, not to diagnose a patient's condition.
No
The device description clearly states it is a liquid control material prepared from human urine with added substances, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the performance of laboratory urine toxicology confirmatory procedures." This indicates it's used in vitro (outside the body) to assess the accuracy of a diagnostic test.
- Device Description: It's a "quality control urine" prepared from human urine with added substances, designed to be used in a laboratory setting.
- Intended User / Care Setting: The intended user is a "laboratory," which is a typical setting for IVD testing.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the information is about the performance of the toxicology test itself.
N/A
Intended Use / Indications for Use
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Product codes
DIF
Device Description
Liquichek Urine Toxicology Control is 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
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urine Toxicology Control (Level C1). Product claims are as follows:
- 30 days at 2-8°C.
- Three years stored at 2-8°C
Real time studies will be ongoing to support the shelf life of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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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APR 2 9 2005
Page 1 of 2
Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Level C1)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
March 9, 2005
2.0 Device Identification
Product Trade Name:
Liquichek Urine Toxicology Control
| Common Name: | Drug Mixture Control |
|---|---|
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
Device to Which Substantial Equivalence is Claimed 3.0
Liquichek Urine Toxicology Control Bio-Rad Laboratories Irvine, California
Docket Number: K033404
4.0 Description of Device
Liquichek Urine Toxicology Control is 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.
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.
1
Comparison of the new device with the Predicate Device 6.0
The new Liquichek Urine Toxicology Control (Level C1) claims substantial equivalence The now Eiquichek Urine Toxicology Control (Level C1) currently in commercial distribution (K033404). The new Liquichek Urine Toxicology Control contains MDMA, MDA and MDEA and the predicate device does not.
| Characteristics | Bio-Rad Liquichek Urine Toxicology Control
(Level C1)
(Predicate Device K033404) | Bio-Rad Liquichek Urine Toxicology Control
(Level C1)
(New Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
| 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 2-8°C | 30 days at 2-8°C |
| | Differences | |
| Drugs | Contains:
d-Amphetamine
d-Methamphetamine
Secobarbital
Amobarbital
Butalbital
Pentobarbital
Phenobarbital
Nordiazepam
a-hydroxyalprazolam
11-Nor-Δ-9-THC-9-COOH
Benzoylecgonine
Ethanol
LSD
Methadone
Methaqualone
Morphine-3-β-D-glucuronide
Codeine
Phencyclidine
Norpropoxyphene
Creatinine
Specific Gravity
pH
Does not contain:
MDMA
MDA | Contains:
d-Amphetamine
d-Methamphetamine
Secobarbital
Amobarbital
Butalbital
Pentobarbital
Phenobarbital
Nordiazepam
α -hydroxyalprazolam
11-Nor-Δ-9-THC-9-COOH
Benzoylecgonine
Ethanol
LSD
Methadone
Methaqualone
Morphine-3-β-D-glucuronide
Codeine
Phencyclidine
Norpropoxyphene
Creatinine
Specific Gravity
pH
MDMA
MDA
MDEA |
| Table 1. Similarities and Differences between new and predicate device. | |
|---|---|
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 (Level C1). Product claims are as follows:
- 30 days at 2-8°C. 7.1 Open vial:
- Three years stored at 2-8°C 7.2 Shelf Life:
Real time studies will be ongoing to support the shelf life of this product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 2005
Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine CA 92618-2017
K050682 Re:
Trade/Device Name: Liquichek Urine Toxicology Control ( Level C1) Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: March 10, 2005 Received: March 16, 2005
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 for ass sured in the 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 r rease of acress a determination that your device complies with other requirements of the Act that 1197 has 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 (QS) regulation (21 CFR Part 820).
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough finding of substantial equivalence of your device to a legally premarket notification - The sults in a classification 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 actuatising of your device, please contact the Office of In or questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other belief general mensactional 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
| Device Name: | Liquichek Urine Toxicology Control (Level C1) |
|---|---|
| Indications For Use: | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory 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)
Albert Ca
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050682