(114 days)
Not Found
No
The device is a quality control material for laboratory testing and does not involve any analytical or interpretive functions that would typically utilize AI/ML. The description focuses on its composition and stability.
No
The device is described as a quality control urine used to monitor the precision of laboratory urine toxicology testing procedures. It is not intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device is described as a "quality control urine to monitor the precision of laboratory urine toxicology testing procedures," not to diagnose patients. It is used to ensure the accuracy of testing equipment, not to directly provide patient diagnoses.
No
The device description clearly states it is a liquid control material prepared from human urine with added substances, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory urine toxicology testing procedures." This indicates it's used in a laboratory setting to evaluate the performance of diagnostic tests.
- Device Description: It's a "quality control urine" prepared from human urine with added substances. This is a typical description of a control material used in IVD testing.
- Intended User / Care Setting: It's intended for "laboratory urine toxicology testing procedures," which is a common setting for IVD use.
- Predicate Device: The mention of a predicate device (K022707; Liquichek Urine Toxicology Control) which is also a control material for urine toxicology, further supports its classification as an IVD.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is a control and not a diagnostic test itself, it is an essential component used with diagnostic tests to ensure their accuracy and reliability, making it fall under the umbrella of IVD products.
N/A
Intended Use / Indications for Use
Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Product codes
DIF
Device Description
Liquichek Opiate Control is prepared from human urine with added drugs of abuse, 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
laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial and shelf life stability for the Liquichek Opiate Control. Product claims are as follows: to establish claims are as follows:
- 7.1 Open vial Stability: Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C.
- 7.2 Shelf Life Stability: Three years when stored at -20 to -70°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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K@q 3577
Bio-Rad Laboratories Premarket Notification Section 510 (k) for Liquichek Opiate Control Summary of Safety and Effectiveness
Page 1 of 2
MAR 1 2 2010
Summary of Safety and Effectiveness Liquichek Opiate Control
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 Specialist (949) 598-1467 Telephone:
Date of Summary Preparation
March 10, 2010
2.0 DEVICE IDENTIFICATION
Product Trade Name: Common Name:
Liquichek Opiate Control Drug Mixture Control
Classifications: Product Code: Regulation Number:
Class I DIF 21 CFR 862.3280
3.0 DEVICE WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
Liquichek Urine Toxicology Control (Levels S1E and S2E) Bio-Rad Laboratories Irvine, California
Docket Number: K022707
4.0 Description of Device
Liquichek Opiate Control is prepared from human urine with added drugs of abuse, 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
Liguichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
008_SEE_Liquichek Opiate 03/10
1
Comparison of the new device with The Predicate Device 6.0
Liquichek Opiate Control claims substantial equivalence to Liquichek Urine Toxicology Control currently in commercial distribution (K022707).
Table 1. Similarities and Differences between new and predicate device.
| Bio-Rad Liquichek Opiate Control | Bio-Rad Liquichek Urine Toxicology Control | |
|---|---|---|
| Characteristics | (New Device) | (Predicate Device K022707) |
| Similarities | ||
| Intended Use | Liquichek Opiate Control is intended for use as quality | |
| control urine to monitor the precision of laboratory | ||
| urine toxicology testing procedures for the analytes | ||
| listed in this package insert. | Liquichek Urine Toxicology Control is intended for use | |
| as quality control urine to monitor the performance of | ||
| laboratory urine toxicology enzyme immunoassay | ||
| (EIA) screening procedures. | ||
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Open Vial | 30 days at 2-8°C | 30 days at 2-8°C |
| Differences | ||
| Storage | ||
| (Unopened) | -20° to -70°C until expiration date | 2-8°C until expiration date |
| Fill Volume | 5 mL | 10 mL |
| Analytes | Claims for: | |
| Buprenorphine | ||
| EDDP | ||
| Fentanyl | ||
| Methadone | ||
| 6-Monoacetylmorphine (6-MAM, 6-AM) | ||
| Oxycodone | Claims for: | |
| d-Methamphetamine | ||
| Secobarbital | ||
| Lormetazepam | ||
| 11-Nor-A-9-THC-9-COOH | ||
| Benzoylecgonine | ||
| Ethanol | ||
| LSD | ||
| Methadone | ||
| Methaqualone Morphine (Free) | ||
| Phencyclidine | ||
| Propoxyphene | ||
| Nortriptyline | ||
| Creatinine | ||
| Specific Gravity | ||
| pH | ||
| Does not claim: | ||
| d-Methamphetamine | ||
| Secobarbital | ||
| Lormetazepam | ||
| 11-Nor-A-9-THC-9-COOH | ||
| Benzoylecgonine | ||
| Ethanol | ||
| LSD | ||
| Methaqualone | ||
| Morphine (Free) | ||
| Phencyclidine | ||
| Propoxyphene | ||
| Nortriptyline | Does not claim: | |
| Buprenorphine | ||
| EDDP | ||
| Fentanyl | ||
| 6-Monoacetylmorphine (6-MAM, 6-AM) | ||
| Oxycodone |
7.0 SUMMARY OF PERFORMANCE DATA
Stability studies have been performed to determine the open vial and shelf life stability for the Liquichek Opiate Control. Product claims are as follows: to establish claims are as follows:
- 7.1 Open vial Stability: Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C.
- 7.2 Shelf Life Stability: Three years when stored at -20 to -70°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.
008_SEE_Liquichek Opiate 03/10
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Bio-Rad Laboratories c/o Ms. Suzanne Parsons Regulatory Affairs Specialist 9500 Jeronimo Road Irvine, CA 92618-2017
MAR 1 2 2010
Re: K093577
Trade Name: Liquichek™ Opiate Control Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical toxicology control material. Regulatory Class: Class I, reserved Product Codes: DIF Dated: January 08, 2010 Received: January 22, 2010
Dear Ms. Parsons:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2
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/MedicalDevices/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. 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 Form
510(k) Number (if known): K093577
Device Name: Liquichek™ Opiate Control
Indications for Use: Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
and the control control control of the control of
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 093577
Page 1 of _1