(19 days)
Liquichek Serum Volatiles Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device called "Liquichek Serum Volatiles Control," focusing on its intended use, description, and comparison to a predicate device for substantial equivalence determination by the FDA. It does not include specific performance metrics, test methodologies, or study results typically associated with device performance validation.
Therefore, I cannot provide the requested information in the specified format.
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DEC 14 1998
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Bio-Rad Laboratories
leronimo Roan vine. California 92618-2017 lenhone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation November 20, 1998
Device (Trade & Common Name) Liquichek Serum Volatiles Control
Classification Name CFR 862.1660: Quality Control Materials (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Bio-Rad Liquichek Ethanol/Ammonia Control Bio-Rad Laboratories Irvine, California
Statement of Intended Use
Liquichek Serum Volatiles Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience.
This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek Serum Volatiles Control and the devices to which substantial equivalence is claimed.
| Bio-Rad LiquichekEthanol/Ammonia Control | Bio-Rad LiquichekSerum Volatiles Control | |
|---|---|---|
| IntendedUse | An assayed quality controlserum to monitor theprecision of laboratorytesting procedures for theanalytes listed in thepackage insert. | An assayed quality controlserum to monitor theprecision of laboratorytesting procedures for theanalytes listed in thepackage insert. |
| Form | Liquid | Liquid |
| Matrix | Bovine Serum | Human Serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | Ammonia, Ethanol | Acetone, Ethanol, EthyleneGlycol, Isopropanol,Methanol |
| Open VialClaim | 20 Days at 2-8°C | 10 Days at 2-8°C |
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DEC 1 4 1998
Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diaqnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K984225 Re: Liquichek Serum Volatiles Control Trade Name: Requlatory Class: I Product Code: JJY Dated: November 24, 1998 November 25, 1998 Received:
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek Serum Volatiles Control
Indications for Use:
Liquichek Serum Volatiles Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| Prescription Use | |
|---|---|
| OR Over-The Counter Use |
(Division Sign-Off)
31 Division of Clinical Laboratory Devices
510(k) Number
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.