(85 days)
Lyphochek Anemia 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 product insert.
Not Found
The provided document is a 510(k) summary for the Bio-Rad Lyphochek Anemia Control, which is a quality control serum. This type of device is classified as a Class I multi-analyte control and is primarily intended to monitor the precision of laboratory testing procedures.
Regulatory submissions for quality control materials, like the Lyphochek Anemia Control, typically do not involve studies with "acceptance criteria" or "proving a device meets criteria" in the same way that a diagnostic device or an AI/ML algorithm would. These products are assessed for their manufacturing quality, stability, and suitability for their intended purpose as assayed controls. The focus is on demonstrating substantial equivalence to an existing legally marketed predicate device, rather than proving a specific performance metric against a clinical ground truth.
Therefore, the requested information elements related to AI algorithm performance, human reader studies, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and are not found in the provided 510(k) summary.
The document states that the device is "substantially equivalent" to the predicate device Bio-Rad Lyphochek Anemia Control (K812635), implying that it performs similarly and has the same intended use.
Here's a breakdown of the applicable information:
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A table of acceptance criteria and the reported device performance:
- Not applicable in the context of an AI/ML algorithm or diagnostic device. For a quality control material, acceptance criteria would typically relate to manufacturing specifications, stability, and analyte values falling within specified ranges. This information is usually found in the product's internal design controls and quality assurance documentation, not typically in the public 510(k) summary, which focuses on substantial equivalence for regulatory clearance. The 510(k) summary provided does not contain specific performance data or acceptance criteria tables as would be expected for a diagnostic or AI device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation for this type of quality control product. Substantial equivalence is generally demonstrated through comparison of device characteristics, manufacturing processes, and intended use to a predicate, not through a performance study on a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth for a test set is established for a quality control material in this regulatory context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication for ground truth is described.
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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:
- Not applicable. This device is a quality control product, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a quality control material, the "ground truth" (or target values) for its analytes are typically assigned through a robust value assignment process by the manufacturer, often using reference methods and/or multiple instruments. This is part of the product's characterization and not a "ground truth" derived from clinical cases for performance evaluation.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable. No training set.
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Image /page/0/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 a black rectangle with rounded corners, and the words "BIO-RAD" are written in white letters inside the rectangle. The plus sign in the middle is slightly larger than the other letters.
Bio-Rad Laboratories Diagnostics Group 00 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
NOV - 9 1999
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 August 13, 1999
Device (Trade & Common Name) Lyphochek Anemia Control
Classification Name Class I, 75JJY CFR 862.1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
Lyphochek Anemia Control Bio-Rad Laboratories Irvine, California K812635
Statement of Intended Use
Lyphochek Anemia 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 product insert.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV - 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K992741 Re: Trade Name: Lyphochek Anemia Control Regulatory Class: I Product Code: JJY Dated: August 13, 1999 Received: August 16, 1999
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 OS 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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K992741 510(k) Number: Device Name: Lyphochek Anemia Control
Indications for Use:
Lyphochek Anemia 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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K992741 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR Over-The Counter Use | |
|---|---|---|
| ------------------ | --------------------------------------------------------- | ------------------------- |
§ 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.