(26 days)
Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This product is prepared from human blood with chemicals and preservatives added. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek Whole Blood Volatiles Control, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the intended use and stability of the device, rather than specific performance metrics against a numerical acceptance criterion for e.g., accuracy or sensitivity. The acceptance criteria here relate to demonstrating that the control material maintains its stability over time and is suitable for its intended purpose (monitoring precision).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." The new device's intended use is identical to the predicate device. |
| Open Vial Stability | "5 days at 2 to 8°C." |
| Shelf Life | "2 years at 2 to 8°C." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Stability studies have been performed," but it does not specify the sample size used for these studies.
The data provenance is Bio-Rad Laboratories, the device manufacturer. The type of study described (stability studies) is inherently prospective as it involves tracking the product's performance over time. The country of origin for the data is not explicitly stated, but as Bio-Rad Laboratories is based in Irvine, California, it is likely United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or provided in the current document. The device is a quality control material, meaning its "ground truth" relates to its inherent stability and consistency, rather than a diagnostic accuracy that would require expert interpretation. The stability studies likely involved laboratory measurements against calibrated standards, not expert adjudication of results.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. See point 3 above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically relevant for diagnostic devices that involve human interpretation of results, which is not the case for a quality control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable or provided. The device is a physical control material, not an algorithm. Its performance is evaluated through its physical and chemical stability, and its ability to consistently provide expected values when tested.
7. Type of Ground Truth Used:
The ground truth for the stability studies would be the measured concentrations of the analytes (Acetone, Ethanol, Isopropanol, Lead, Methanol) within the control material, compared to established reference values or against its initial measured concentrations. This would involve analytical testing and measurement against validated standards or methods, rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This information is not applicable or provided. The device is a physical control material and does not involve a "training set" in the machine learning sense. The manufacturing process is controlled to ensure consistency across batches.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided. See point 8 above.
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Summary of Safety and Effectiveness Liquichek Whole Blood Volatiles Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
June 08, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek Whole Blood Volatiles Control |
|---|---|
| Common Name: | Clinical Toxicology Control Material |
| Classifications: | Class I |
| Product Code: | DIF |
| Regulation Number: | 21 CFR 862.3280 |
3.0 Device to Which Substantial Equivalence is Claimed
Whole Blood Tox Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K821975A
4.0 Description of Device
This product is prepared from human blood with chemicals and preservatives added. The control is provided in liquid form for convenience.
5.0 Intended Use
Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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6.0 Preservatives:
The Liquichek Whole Blood Volatiles Control does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
7.0 Comparison of the new device with the Predicate Device
Liquichek Whole Blood Volatiles Control claims substantial equivalence to Whole Blood Tox Control currently in commercial distribution (K821975A).
| Characteristics | Bio-Rad LaboratoriesLiquichek Whole Blood Volatiles Control(New Device) | Bio-Rad LaboratoriesWhole Blood Tox Control(Predicate Device K821975A) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Whole Blood Volatiles Control is intended for useas a quality control material to monitor the precision oflaboratory testing procedures for the analytes listed in thepackage insert. | Use Whole Blood Tox quality control material, assayed, tomonitor the precision of whole blood toxicology testprocedures. |
| Form | Liquid | Liquid |
| Matrix | Whole Blood | Whole Blood |
| Preservatives | Contains preservatives | Contains preservatives |
| Storage (Unopened) | 2°C to 8°CUntil expiration date | 2°C to 8°CUntil expiration date |
| Open Vial | 5 days at 2°C to 8°C | 5 days at 2°C to 8°C |
| Differences | ||
| Analytes | Contains the following analytes:● Acetone● Ethanol● Isopropanol● Lead● MethanolDoes not contain:● Phenylalanine | Contains the following analytes:● Ethanol● Isopropanol● Lead● Methanol● PhenylalanineDoes not contain:● Acetone |
Table 1. Similarities and Differences between new and predicate device.
8.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Whole Blood Volatiles Control. Product claims are as follows:
- 8.1 Open Vial Stability: 5 days at 2 to 8°C.
- 8.2 Shelf Life: 2 years at 2 to 8°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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL - 6 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
K041561 Re: Trade/Device Name: Liquichek Whole Blood Volatiles Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 8, 2004 Received: June10, 2004
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 (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,
Jean M. Cooper MS, DVM.
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
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Indications for Use
510(k) Number (if known):
K04156/
Device Name:
Liquichek Whole Blood Volatiles Control
Indications For Use:
Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Prescription Use V (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)
Alberts Caz
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041561
§ 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.