(114 days)
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.
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.
This submission from Bio-Rad Laboratories is for a Liquichek Opiate Control, which is a quality control material for urine toxicology testing. The documentation does not describe a study involving a medical device with a "device performance" in the typical sense of diagnostic accuracy (sensitivity, specificity, AUC) or an AI algorithm. Instead, it details a 510(k) premarket notification for an in vitro diagnostic (IVD) control material. The "performance data" refers to the stability of the control material itself, not the performance of a diagnostic device it would be used with.
Therefore, many of the requested elements of your query (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training set, training set size, and how training ground truth was established) are not applicable to this type of submission.
Here's an adaptation of the requested table and information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the control material) | Reported Device Performance (Characteristics of the control material) |
|---|---|
| Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2 to 8°C after thawing. | All analytes are stable for 30 days when stored tightly capped at 2 to 8°C. (This is a claim based on completed stability studies, implying the data met the criteria). |
| Shelf Life Stability: Stable for a specified duration (e.g., 3 years) when stored at -20 to -70°C. | Three years when stored at -20 to -70°C. (This is a claim based on initial studies, with real-time studies described as "ongoing" to further support this claim, implying initial data met the criteria). |
| Substantial Equivalence to Predicate Device (for characteristics and intended use) | The device is substantially equivalent to the predicate device (Liquichek Urine Toxicology Control, K022707) in intended use, form (liquid), matrix (urine), and open vial stability. Differences exist in storage (unopened), fill volume, and specific analytes claimed, but these differences did not raise new questions of safety or effectiveness. |
| Intended Use Fulfilment | 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. (The FDA's 510(k) clearance confirms this intended use as acceptable). |
| Composition and Preparation | Prepared from human urine with added drugs of abuse, metabolites, preservatives, stabilizers, and animal origin constituents. (This describes the material as submitted and found acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
As this document describes the stability and characteristics of a quality control material, rather than a diagnostic device's performance on patient data, the concept of a "test set" in the context of diagnostic accuracy is not directly applicable.
The performance data refers to:
- Stability Studies: These involve testing the control material over time under specified conditions. The sample size would be related to the number of vials/batches tested at various time points. This specific number is not provided in the summary.
- Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin for the data is implicitly the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve monitoring the product's characteristics over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the sense of expert consensus on patient cases is not relevant for the stability testing of a quality control material. The 'ground truth' for the stability studies would be the scientifically established chemical stability of the analytes, measured directly in the control material using validated analytical methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among experts on patient diagnoses. This is not a diagnostic device study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with and without AI assistance, in diagnostic tasks. This submission is for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an algorithm or AI device. The "device" is a physical control material.
7. The Type of Ground Truth Used
The "ground truth" for the stability data supporting the claims would be based on analytical measurements (e.g., using validated laboratory assays) of the analyte concentrations within the control material over time and under various storage conditions. This is a direct measurement of the control material's properties, not an expert panel diagnosis or pathology.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained in this context. The "training set" concept is not relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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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
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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 qualitycontrol urine to monitor the precision of laboratoryurine toxicology testing procedures for the analyteslisted in this package insert. | Liquichek Urine Toxicology Control is intended for useas quality control urine to monitor the performance oflaboratory 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:BuprenorphineEDDPFentanylMethadone6-Monoacetylmorphine (6-MAM, 6-AM)Oxycodone | Claims for:d-MethamphetamineSecobarbitalLormetazepam11-Nor-A-9-THC-9-COOHBenzoylecgonineEthanolLSDMethadoneMethaqualone Morphine (Free)PhencyclidinePropoxypheneNortriptylineCreatinineSpecific GravitypH |
| Does not claim:d-MethamphetamineSecobarbitalLormetazepam11-Nor-A-9-THC-9-COOHBenzoylecgonineEthanolLSDMethaqualoneMorphine (Free)PhencyclidinePropoxypheneNortriptyline | Does not claim:BuprenorphineEDDPFentanyl6-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
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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).
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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
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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
§ 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.