(19 days)
Lyphochek Hypertension Markers 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.
Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability. This product contains 0.1% sodium azide as a preservative.
The provided document is a 510(k) summary for the Lyphochek Hypertension Markers Control device. This device is classified as a Class I Quality Control Material (Assayed and Unassayed) and is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes.
However, the 510(k) summary does not contain a study that proves the device meets specific acceptance criteria in terms of performance measures like sensitivity, specificity, accuracy, etc., for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Ciba Corning Diagnostics Renin Control) based on shared technological characteristics and intended use as a quality control material.
The document highlights the device's characteristics and compares them to the predicate device to justify its marketing. Key information regarding performance studies and acceptance criteria as outlined in your request is not present for this type of device submission. Quality control materials are generally assessed for their stability, homogeneity, and assigned values, rather than through clinical performance studies against a "ground truth" in the same way a diagnostic device would be.
Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance table, sample sizes for test/training sets, expert qualifications, or details about MRMC studies because this information is not part of this 510(k) submission for a quality control material.
The 510(k) summary focuses on the following:
- Intended Use: To monitor the precision of laboratory testing procedures for specified analytes.
- Technological Characteristics: Comparison to a predicate device regarding intended use, levels, form, open vial claim, matrix, and storage.
The closest information to "acceptance criteria" for a quality control material would be related to its manufacturing specifications, stability, and the accuracy of its assigned analyte values, none of which are detailed as performance "acceptance criteria" with study results in this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in a bold, sans-serif font.
Bio-Rad
Laboratories
OS F Miraloma Avenu heim. CA 92806 lephone (714) 630-640 I Free (800) 854-6737
JUN 16 1997
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation May 27, 1997
Device (Trade & Common Name) Lyphochek Hypertension Markers Control
Classification Name Class 1, 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Renin Control Ciba Corning Diagnostics
Statement of Intended Use
Medfield, MA
Lyphochek Hypertension Markers Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
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 Lyphochek Hypertension Markers Control and the device to which substantial equivalence is claimed.
| Bio-Rad Lyphochek HypertensionMarkers Control | Ciba Corning DiagnosticsRenin Control | |
|---|---|---|
| IntendedUse | An assayed quality control serumto monitor the precision oflaboratory testing procedures forthe analytes listed in thepackage insert. | To monitor the precision and theaccuracy of clinical chemistry testprocedures which analyze renaland adrenal function. |
| Levels | Three | Two |
| Form | lyophilized | lyophilized |
| OpenVialClaim | 21 Days at 2-8°C with theexception of ACTH which shouldbe assayed immediately afterreconstitution | 8 hours at 2-8°C-- |
| Matrix | defibrinated human plasma | human plasma |
| Storage | 2-8°C | 2-8°C |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 6 1997
Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806
Re: K971952 Lyphochek Hypertension Markers Control Requlatory Class: I Product Code: JJY Dated: May 27, 1997 Received: May 28, 1997
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 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 requlation 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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971952 510(k) Number: Device Name: Lyphochek Hypertension Markers Control 参 Indications for Use:
Lyphochek Hypertension Markers 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
(1
Over-The Counter Use _ OR
38
§ 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.