Lyphochek Coagulation Control is prepared from human plasma with added constituents of animal origin, purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.

AI/ML Overview

This document is a 510(k) summary for the Lyphochek Coagulation Control device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance for a novel AI/software-based device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission for a laboratory control product.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" in the way one would for a diagnostic test with metrics like sensitivity or specificity. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the new device to a predicate device.

Characteristic	Bio-Rad Lyphochek Coagulation Control (New Device)	Bio-Rad Lyphochek Coagulation Control (Substantially Equivalent Device)
Intended Use	A quality control plasma to monitor the precision of citrated coagulation systems.	A quality control plasma to monitor the precision of citrated coagulation systems.
Form	Lyophilized	Lyophilized
Matrix	Human based control.	Human based control.
Storage	2-8°C	2-8°C
Open Vial Claim	24 hours days when stored tightly capped at 2-25°C.	24 hours days when stored tightly capped at 2-25°C.
Analytes	Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), Thrombin Time (TT).	Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen.

Device Performance Study (as implied by substantial equivalence):

The "study" implicitly referenced is a comparison of the new device's characteristics against those of a legally marketed predicate device (K964963). The new device adds more analytes (Antithrombin III and Thrombin Time) compared to the predicate, but otherwise maintains identical characteristics for the common analytes and other features, strongly suggesting comparable precision monitoring capabilities. No specific performance metrics (like coefficient of variation or bias data) are provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. This type of submission relies on demonstrating similarity in composition and manufacturing rather than extensive clinical performance data with a "test set" sample size in the traditional sense.
Data Provenance: Not specified. It's a manufacturing and compositional comparison, not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of diagnostic accuracy (which would involve expert review) is not relevant for this coagulation control product's 510(k) submission.

4. Adjudication method for the test set

Not Applicable. No test set or expert adjudication 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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" for this submission is the characteristics and established performance of the predicate device, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not Applicable. This is not a machine learning/AI device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. (See #8)

Summary

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Bio-Rad Laboratories e (949) 598-

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 March 12, 1999

Device (Trade & Common Name) Lyphochek Coagulation Control

Classification Name Class II, 81GGN CFR 864.5425: Plasma Coagulation Control

Devices to Which Substantial Equivalence is Claimed Lyphochek Coagulation Control Bio-Rad Laboratories Irvine, California K964963

Statement of Intended Use

Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

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boratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200

Description of the Device

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Lyphochek Coagulation Control and the devices to which substantial equivalence is claimed.

	Bio-Rad Lyphochek CoagulationControl (New Device)	Bio-Rad Lyphochek CoagulationControl (Substantially EquivalentDevice)
IntendedUse	A quality control plasma to monitorthe precision of citrated coagulationsystems.	A quality control plasma to monitorthe precision of citrated coagulationsystems.
Form	Lyophilized	Lyophilized
Matrix	Human based control.	Human based control.
Storage	2-8°C	2-8°C
Open VialClaim	24 hours days when stored tightlycapped at 2-25°C.	24 hours days when stored tightlycapped at 2-25°C.
Analytes	Prothrombin Time (PT), ActivatedPartial Thromboplastin Time (APTT),Fibrinogen, Antithrombin III (AT III),Thrombin Time (TT).	Prothrombin Time (PT), ActivatedPartial Thromboplastin Time (APTT),Fibrinogen.

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Premarket Notification Truthful and Accurate Statement

I certify that, in my capacity as Regulatory Affairs Supervisor of Bio-Rad Laboratories, ECS Division, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Cabret Cluft

3/12/55
Date

Elizabeth Platt Regulatory Affairs Supervisor

Date

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, represented by three curved lines.

APR 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine. California 92618-2017

Re: K990858

Trade Name: Lyphochek Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 31, 1999 Received: April 2, 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 (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 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: K990858
Device Name: Lyphochek Coagulation Control

Indications for Use:

Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Peter E. Majurin

al Laboratory Devi

(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 _

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.