(44 days)
Lyphochek Whole Blood Metals Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Whole Blood Metals Control is prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
The provided document describes a medical device, the Lyphochek Whole Blood Metals Control, and its 510(k) submission for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, the document focuses on regulatory approval based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, or study methodologies because this document does not contain that type of data.
The relevant information from the document is related to the regulatory comparison:
- Device Name: Lyphochek Whole Blood Metals Control
- Intended Use: An assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
- Predicate Device: Lyphochek Whole Blood Control (K980871)
- Basis for Approval: Substantial equivalence to the predicate device.
The tables in the document compare the technological characteristics of the new device with the predicate device, showing their similarities, rather than presenting a performance study against predefined acceptance criteria.
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JAN 29 1999
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9', '8', '4', '4', '7', and '7'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
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Laboratories
0 Jeronimo Road ine, California 92618-2 lephone: (949) 598-120
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 16, 1998
Device (Trade & Common Name) Lyphochek Whole Blood Metals Control
Classification Name Class I, CFR 862.1660: Multi-Analyte Control (Assayed and Unassayed) 75JJY
Devices to Which Substantial Equivalence is Claimed Lyphochek Whole Blood Control Bio-Rad Laboratories, Irvine, California K980871
Statement of Intended Use
Lyphochek Whole Blood Metals Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white and features the company name in a bold, sans-serif font. The logo is encased in a rounded rectangle.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Lyphochek Whole Blood Metals Control is prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Whole Blood Metals Control and the device to which substantial equivalence is claimed.
| Lyphochek Whole Blood MetalsControl | Lyphochek Whole Blood Control | |
|---|---|---|
| IntendedUse | An assayed quality control tomonitor the precision oflaboratory testing procedures forthe analytes listed in thepackage insert. | An assayed quality control materialto monitor the precision oflaboratory testing procedures forthe analytes listed in the packageinsert. |
| Form | Lyophilized | Lyophilized |
| OpenVialClaim | 14 days when stored tightlycapped at 2-8°C with thefollowing exception: red cellfolate will be stable for 3 days. | 14 days when stored tightlycapped at 2-8°C with the followingexception: red cell folate will bestable for 3 days. |
| Matrix | Human Whole Blood | Human Whole Blood |
| Storage | 2-8°C | 2-8°C |
| Analytes | Lead, Red Cell Folate | Cyclosporine, FK-506, Lead, RedCell Folate |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 29 1999
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories ECS 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984477
Trade Name: Lyphochek Whole Blood Metals Control Regulatory Class: I Product Code: 75 JJY Dated: December 16, 1998 Received: December 16, 1998
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 Regulations, 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 Regulation (OS) 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 regulation (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 general 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K98-4477
Device Name: Lyphochek Whole Blood Metals Control
Indications for Use:
510(k) Number:
Lyphochek Whole Blood Metals Control is intended for use as an assayed quality Eyphoonen vnitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K984477
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
Over-The Counter Use __ OR
32
§ 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.