(37 days)
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.
Liquichek 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 text regarding the acceptance criteria and study for the Liquichek Urine Toxicology Control (Levels S1S and S2S):
The provided document is a 510(k) summary for a medical device (quality control material for toxicology testing). It claims substantial equivalence to a predicate device and does not detail a study conducted to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study comparing it to an external reference standard. Instead, the "study" referenced focuses on stability testing to support product claims.
Therefore, many of the requested fields cannot be directly extracted from this document as they pertain to a type of performance study that was not conducted or reported here.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Implied from predicate comparison and claims) | Reported Device Performance |
|---|---|
| Intended Use: Quality control to monitor performance of laboratory urine toxicology EIA screening procedures. | Matches intended use of predicate device. |
| Form: Liquid | Liquid |
| Matrix: Urine | Urine |
| Storage (Unopened): 2-8°C until expiration date | 2-8°C until expiration date |
| Open Vial Stability: 30 days at 2-8°C | Claimed: 30 days at 2-8°C (supported by stability studies) |
| Shelf Life: (Not explicitly stated as an initial acceptance criteria, but a claim to be supported) | Claimed: Three years stored at 2-8 °C (supported by ongoing real-time studies for future validation) |
| Drug Content: Specific panel of drugs. | The new device contains a modified panel of drugs compared to the predicate, with MDMA added and several others removed. This is a difference, not a direct performance measure against a criterion. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for a clinical performance test. The "performance data" section only references "stability studies."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of study (stability) does not typically involve expert review for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a quality control material, not an AI-powered diagnostic device. An MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a quality control material.
7. The type of ground truth used:
- For the stability studies, the "ground truth" would be the known concentration of the spiked drugs in the control material, measured by a reference method over time.
8. The sample size for the training set:
- Not applicable. This device is a quality control material, not an algorithm that requires training data.
9. How the ground truth for the training set was established:
- Not applicable.
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Summary of Safety and Effectiveness Liquichek Urine Toxicology Control (Levels S1S and S2S)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
October 15, 2004
Device Identification 2.0
Product Trade Name: Liquichek Urine Toxicology Control (Levels S1S and S2S)
| Common Name: | Drug Mixture Control |
|---|---|
| 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 (Levels S1E and S2E) Bio-Rad Laboratories Irvine, California
Docket Number: K022707
4.0 Description of Device
Liquichek 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 Urine Toxicology Control (Levels S1S and S2S) is intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.
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6.0 Comparison of the new device with the Predicate Device
The new Liquichek Urine Toxicology Controls (Levels S1S and S2S) claimsubstantial equivalence to the Liquichek Urine Toxicology Controls (Levels S1E and S2E) currently in commercial distribution (K022707).
| Bio-Rad Liquichek Urine Toxicology Control(Levels S1E and S2E)(Predicate Device K022707) | Bio-Rad Liquichek Urine Toxicology Control(Levels S1S and S2S)(New Device) | |
|---|---|---|
| Characteristics | Similarities | |
| Intended Use | Liquichek Urine Toxicology Control (Levels S1E and S2E) are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures. | Liquichek Urine Toxicology Control (Levels S1S and S2S) are intended for use as quality controls urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening 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: | Contains: |
| d-Methamphetamine9-COOH-11-nor-Δ9-THCBenzoylecgonineMorphine (Free)PhencyclidineSecobarbitalLormetazepamEthanolLSDMethadoneMethaqualonePropoxypheneTricyclic Antidepressants (nortriptyline) | d-Methamphetamine9-COOH-11-nor-Δ9-THCBenzoylecgonineMorphine (Free)Phencyclidine3,4-Methylenedioxymethamphetamine (MDMA) | |
| Does not contains | Does not contains | |
| 3,4-Methylenedioxymethamphetamine (MDMA) | SecobarbitalLormetazepamEthanolLSDMethadoneMethaqualonePropoxypheneTricyclic Antidepressants (nortriptyline) |
Table 1. Similarities and Differences between new and predicate device.
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urine Toxicology Control Levels S1S and S2S. Product claims are as follows:
- 7.1 Open vial: 30 days at 2-8°C.
- 7.2 Shelf Life: Three years stored at 2-8 °C
- Real time studies will be ongoing to support the shelf life of this product. 7.3
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 4 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/ Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618
K042865 Re:
R042005
Trade/Device Name: Liquichek Urine Toxicology Control (Level S1S and S2S) Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 15, 2004 Received: October 18, 2004
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfall in the encreases in 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). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy aters, worksions 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 or and I 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).
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Page 2 -
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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Division of Small Manufacturers, International 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA 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):
| Device Name: | Liquichek Urine Toxicology Control (Level S1S and S2S) |
|---|---|
| Indications For Use: | 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. |
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)
Albert Sal
Division
Organ at the Vites Dlags De ma & Evelopation an
51:000 K042865
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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.