(36 days)
Lyphochek Maternal Serum 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 Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. The control is provided in lyophilized form for increased stability.
The provided text is a 510(k) summary for the Bio-Rad Lyphochek Maternal Serum Control, which is a quality control device. It does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes to establish acceptance criteria in the typical sense of a medical diagnostic device's performance. Instead, it compares the technological characteristics of the new device to a predicate device to claim substantial equivalence.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this document. The "device performance" here refers to its physical and chemical characteristics as a control serum, rather than its diagnostic accuracy.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or concordance. Instead, it compares the characteristics of the investigational device (Lyphochek Maternal Serum Control) to a predicate device (Lyphochek Immunoassay Plus Control) to demonstrate substantial equivalence. The "performance" being described relates to the control's properties.
| Characteristic | Bio-Rad Lyphochek Maternal Serum Control (Investigational Device) | Bio-Rad Lyphochek Immunoassay Plus Control (Predicate Device) |
|---|---|---|
| Intended Use | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Open Vial Claim | 10 days when stored tightly capped at 2-8°C. | 7 days when stored tightly capped at 2-8°C with exceptions for certain analytes (3 days for C-Peptide, Folate, PSA; immediately for ACTH, Calcitonin, Gastrin). |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | AFP (Alpha-Fetoprotein), Estriol, Free, HCG-Beta Subunit | AFP (Alpha-Fetoprotein), Estriol, Free, HCG-Beta Subunit, Plus other analytes. |
Acceptance Criteria Implied: The acceptance criteria are implicitly that the investigational device's characteristics (intended use, form, open vial claim, matrix, storage, and key analytes) are either identical to or demonstrably equivalent to the predicate device to ensure it performs its function as a quality control. For the open vial claim, the acceptance criteria for the investigational device seems to be that it is stable for at least as long as the predicate for common analytes, or that any differences are well-supported and acceptable.
Study Proving Acceptance Criteria: The document describes a comparison, not a formal study in the sense of a clinical trial. The "study" here is the declaration of these comparative characteristics. The "proof" is the presented table and the assertion of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable. There is no "test set" of patient data or clinical samples in the traditional sense for evaluating diagnostic accuracy. The device itself is a control material, and its characteristics are evaluated (e.g., stability, matrices). The document does not specify sample sizes for these internal evaluations of the control material's properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. "Ground truth" in the context of diagnostic accuracy via expert consensus is not relevant for a quality control material where performance is assessed by its chemical and physical properties against a standard or predicate.
4. Adjudication Method for the Test Set
This is not applicable, as there is no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This is not applicable. MRMC studies are used to evaluate the diagnostic performance of devices, often involving human readers, which is not the purpose of a quality control device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The Lyphochek Maternal Serum Control is a physical reagent, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material's characteristics (like stability or composition) would be established through established laboratory testing methodologies, analytical chemistry, and stability studies. The document does not explicitly detail these methods for the new device, but it implies they were done to support the presented characteristics, and presumably, industry standards for quality control manufacturing were followed. For the purpose of substantial equivalence, the "ground truth" is essentially the established characteristics of the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device or a device that learns from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a quality control material to a legally marketed predicate device based on technological characteristics. It does not involve a clinical study to assess diagnostic performance against patient outcomes or expert interpretations, and therefore, many of the typical acceptance criteria and study details for such devices are not present in this document. The "acceptance criteria" are the characteristics of the predicate device, and the "study" is the comparison made by the manufacturer to those characteristics.
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Image /page/0/Picture/0 description: The image shows the date "FEB 2 1999" in a simple, sans-serif font. The letters and numbers are printed in black ink. The month "FEB" is abbreviated and followed by the day "2" and the year "1999".
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is in black and white, with the words "BIO-RAD" in bold, white letters against a black, rounded rectangle. The plus sign in the middle of the word is slightly larger than the other letters.
Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: (949) 598-1200
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 22, 1998
Device (Trade & Common Name) Lyphochek Maternal Serum Control
Classification Name Class I, CFR 862.1660: Multi-Analyte Control (Assayed and Unassayed) 75JJY
Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, California K981532
Statement of Intended Use
Lyphochek Maternal Serum 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, with the words "BIO-RAD" in bold, sans-serif letters. The logo is simple and recognizable, and it is used on a variety of Bio-Rad products and marketing materials. The logo is enclosed in a black rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Lyphochek Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. 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 Maternal Serum Control and the device to which substantial equivalence is claimed.
| Bio-Rad Lyphochek MaternalSerum Control | Bio-Rad Lyphochek ImmunoassayPlus Control | |
|---|---|---|
| IntendedUse | An assayed quality control serumto monitor the precision oflaboratory testing procedures forthe analytes listed in the packageinsert. | An assayed quality control serumto monitor the precision oflaboratory testing procedures forthe analytes listed in the packageinsert. |
| Form | Lyophilized | Lyophilized |
| OpenVialClaim | 10 days when stored tightlycapped at 2-8°C. | 7 days when stored tightly cappedat 2-8°C with the followingexceptions: (1) C-Peptide, Folateand PSA are stable for 3 daysafter reconstitution. (2) ACTH,Calcitonin and Gastrin should beassayed immediately afterreconstitution. |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | AFP (Alpha-Fetoprotein)Estriol, FreeHCG-Beta Subunit | AFP (Alpha-FetoproteinEstriol, FreeHCG-Beta SubunitPlus other analytes. |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a serif typeface, and the overall impression is one of official documentation or signage.
Public Health Service
2 1999 FEB
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
K984594 Re:
Trade Name: Lyphochek Maternal Serum Control Regulatory Class: I Product Code: JJY Dated: December 23, 1998 Received: December 28, 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 (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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Page 1 of 1
510(k) Number: K984594
Device Name: Lyphochek Maternal Serum Control
Indications for Use:
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Lyphochek Maternal Serum Control is intended for use as an assayed quality control Lyphochek matermal Ocrain Somethor testing procedures for the analytes listed in the package insert.
Cooper
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of Clinical Lan
510(k) Number
(Division Sign-Off)
Division of Clinical Laboratory Levices
K984594
(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
§ 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.