(13 days)
Lyphochek Immunoassay Plus 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 Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. The control is provided in lyophilized form for increased stability.
This 510(k) submission (K981532) for the Lyphochek Immunoassay Plus Control does not contain a detailed study with acceptance criteria and device performance results in the way a typical medical device algorithm or diagnostic test submission might. Instead, it is a submission for a quality control material, and its clearance is based on demonstrating substantial equivalence to a previously cleared device.
Therefore, many of the requested elements of your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or would not be found in this type of submission.
Here's an analysis based on the provided text, focusing on what is available and explaining why other elements are not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic test (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on the characteristics and intended use being the same as the predicate device, with added analytes.
| Feature/Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | "An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." (Identical to predicate) | Met, as the new device shares the same intended use. |
| Form | Lyophilized (Identical to predicate) | Met. |
| Matrix | Human Serum (Identical to predicate) | Met. |
| Storage | 2-8°C (Identical to predicate) | Met. |
| Reconstituted Stability Claim | 7 days at 2-8°C (with specific exceptions for C-Peptide, Folate, PSA, ACTH, Calcitonin, Gastrin) (Identical to predicate) | Met. |
| Added Analytes | Product has added claims for Total Estrogens, Flecainide, IgA, IgG, IgM, Iron, TIBC, Netilmicin, SHBG. (This is a difference from the predicate, but implicitly accepted as an improvement/addition without altering fundamental safety or effectiveness for the control material). | Demonstrated these analytes can be measured by the control material, aligning with its role as a quality control. (Specific performance data for these added analytes is not provided in this summary but would be part of the full submission's justification for equivalence). |
Explanation: For a quality control material, the "performance" is its ability to consistently provide known values for various analytes, allowing laboratories to monitor the precision of their assays. The substantial equivalence argument relies on the new device having equivalent formulation, stability, and intended use to a previously cleared control, with the addition of more analytes being an expansion of utility rather than a change in fundamental function.
2. Sample size used for the test set and the data provenance
- Not Applicable in this summary. This document is a 510(k) summary for a quality control material, not a diagnostic test that measures patient samples. Therefore, there is no "test set" of patient data in the conventional sense. The "testing" involved would typically be characterization of the control material (e.g., lot-to-lot consistency, stability studies, assigned values) rather than a clinical accuracy study. Data provenance would relate to manufacturing and internal validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As there is no "test set" of clinical samples with a "ground truth" to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication process is described.
5. 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 material, not an AI-powered diagnostic tool, and involves no human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Implied by product type. For a quality control material, the "truth" is established by precise laboratory measurements using reference methods and/or expert assignments, which define the expected ranges for the analytes within the control. This is intrinsic to the manufacturing and characterization of the control itself and not an external "ground truth" established for a separate test set.
8. The sample size for the training set
- Not Applicable. Quality control materials do not use "training sets" in the context of machine learning. The "training" in this context would refer to internal validation and manufacturing processes to ensure the control material performs as expected.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. Below the logo, the date MAY 12 1998 is printed. The logo is in bold, black letters, and the date is in a smaller, less bold font. The image is black and white.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 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 April 28, 1998
Device (Trade & Common Name) Lyphochek Immunoassay Plus Control
Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, CA K891475
Statement of Intended Use
Lyphochek Immunoassay Plus 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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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in a rounded rectangle shape. The text "BIO+RAD" is in white, and the background is black.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
Description of the Device
Lyphochek Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. 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 Immunoassay Plus Control and the device to which substantial equivalence is claimed.
| Bio-Rad LyphochekImmunoassay Plus Control | Bio-Rad LyphochekImmunoassay Plus Control(new submission) | |
|---|---|---|
| Intended Use | 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 | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Storage | 2-8°C | 2-8°C |
| ReconstitutedStabilityClaim | 7 days at 2-8°C with thefollowing exceptions: (1) C-Peptide, Folate and PSAare stable for 3 days afterreconstitution, (2) ACTH,Calcitonin and Gastrinshould be assayedimmediately afterreconstitution. | 7 days at 2-8°C with thefollowing exceptions: (1) C-Peptide, Folate and PSA arestable for 3 days afterreconstitution, (2) ACTH,Calcitonin and Gastrinshould be assayedimmediately afterreconstitution. |
| Differences | Current product does nothave claims for thefollowing: Total Estrogens,Flecainide, IgA, IgG, IgM,Iron, TIBC, Netilmicin,SHBG. | Product has added claimsfor the following: TotalEstrogens, Flecainide, IgA,IgG, IgM, Iron, TIBC,Netilmicin, SHBG. |
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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 eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 1998
Elizabeth Platt . Acting Requlatory Affairs/Quality Assurance Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
K981532 Re : Lyphochek Immunoassay Plus Control Requlatory Class: I Product Code: JJY Dated: April 28, 1998 Received: April 29, 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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set " forth in the Quality System Regulation (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 In addition, FDA may publish further announcements action. 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 requlations.
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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/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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510(k) Number: _ Device Name: Lyphochek Immunoassay Plus Control
Indications for Use:
Lyphochek Immunoassay Plus 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.
(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 |
Veronica J. Caluin for A Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
| Number | K981532 |
|---|---|
| -------- | --------- |
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§ 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.