Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

The provided text describes the Liquichek™ D-dimer Control device, which is an assayed quality control intended to monitor the precision of laboratory testing procedures for D-dimer. It's important to note that this device is a control for D-dimer assays, not an D-dimer assay itself. Therefore, the "performance" here refers to its stability and ability to maintain stated analyte levels over time.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are related to its stability (open vial and shelf life). The "reported device performance" directly addresses these stability claims.

Acceptance Criteria	Reported Device Performance
Open Vial Stability: Maintain stability	30 days when stored tightly capped at 2 to 25°C
Shelf Life: Maintain stability	Three years when stored at 2 to 8 °C

2. Sample Size Used for the Test Set and Data Provenance

The document states:

Sample size: Not explicitly stated. The stability studies would have involved multiple vials/lots of the Liquichek™ D-dimer Control.
Data provenance: Not explicitly stated, but implicitly prospective as it involves "stability studies" and "real time studies." The data would originate from Bio-Rad Laboratories.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the traditional sense for this device. The "ground truth" for a quality control material is its assigned value(s) for the analyte (D-dimer) and its stability over time. This is established through internal testing and measurement by the manufacturer (Bio-Rad Laboratories) using validated assays, not by external experts reviewing test results. There's no mention of experts establishing a ground truth for clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need to be resolved. For a quality control device's stability study, there is no human interpretation or adjudication process of this nature. The results are quantitative measurements against established analytical methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading scans) and AI might assist them. The Liquichek™ D-dimer Control is a quality control material, not a diagnostic tool where human readers are involved in interpreting its "output" to make a clinical decision.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This device is a consumable quality control material; it is not an algorithm or an AI system that would have a standalone performance. Its "performance" relates to its chemical and biological stability and its ability to provide consistent D-dimer values over its stated shelf life and open-vial period.

7. The Type of Ground Truth Used

The ground truth used for this device's performance (stability claims) is based on analytical measurements performed by the manufacturer, Bio-Rad Laboratories. These measurements would quantify the D-dimer levels within the control material over time, under specified storage conditions, using validated D-dimer assays. These are objective, quantitative laboratory results, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This question is not applicable. The Liquichek™ D-dimer Control is not an AI/ML algorithm or a diagnostic test that requires a training set. Its manufacturing process involves formulation and quality control validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. There is no training set for this type of medical device.

Summary

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K030182

Page 1 of 2

Summary of Safety and Effectiveness Liquichek™ D-dimer Control

1.0 Submitter

FEB 2 4 2003

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:

Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

January 15, 2003

2.0 Device Identification

Product Trade Name:	Liquichek™ D-dimer Control
Common Name:	Plasma, Coagulation Control
Classifications:	Class II
Product Code:	GGN
Regulation Number:	CFR 862.5425

3.0 Device to Which Substantial Equivalence is Claimed

STAGO Diagnostica STA-Liatest® Control [N]+[P] Parsippany, New Jersey 07504

Docket Number: K964716

4.0 Description of Device

Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.

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5.0 Statement of Intended Use

Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

6.0 Comparison of the new device with the Predicate Device

The Liquichek™ D-dimer Control claims substantial equivalence to the STAGO STA® -Liatest Control [N] + [P] currently in commercial distribution (K964716).

	Bio-Rad	STAGO Diagnostica
Characteristics	Liquichek™ D-dimer Control	STA-Liatest® Control [N] + [P]
	(New Device)	(Predicate Device K964716)
Similarities
Intended Use	Liquichek D-dimer Control is intended foruse as a quality control to monitor theprecision of D-dimer procedures.	The STA-Liatest® Control [N]+[P] kit is intended foruse as control plasmas (normal and abnormallevels) for intended use: von Willebrand Factor(vWF), free protein S and D-dimer assays on STA®analyzers by the immuno-turbidimetric method.
Levels	Level 1 and Level 2	Normal and abnormal levels
Analytes	D-dimer	D-dimer [Von Willebrand Factor (vWF), free proteinS are also in the controls]
Storage	2°C to 8°C	2°C to 8°C
(Unopened)	Until expiration date	Until expiration date
Differences
Open Vial Claim	30 days at 2 to 25°C	8 hours at 15 to 20°C
Matrix	Processed human plasma with addedconstituents of human and animal origin,and preservatives.	Citrated normal or abnormal plasma.
Form	Liquid	Freeze-dried

Table 1. Similarities and Differences between new and predicate device.

7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek ™ D-dimer Control. Product claims are as follows:

7.1 Open vial: Once the product is opened, the analyte will be stable for 30 days when stored tightly capped at 2 to 25°C.
7.2 Shelf Life: Three years when stored at 2 to 8 °C.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 4 2003

Ms. Maria Zeballos, RAC Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618

Re: K030182

Trade/Device Name: LiquichekTM D-dimer Control Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP; GGN Dated: February 4, 2003 Received: February 5, 2003

Dear Ms. Zeballos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Liquichek™ D-dimer Control Device Name:

Indications for Use:

Liquichek D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

Methods:

bioMerieux Vidas .
Dade Behring BCS/BCT Advanced D-Dimer ●
Dade Behring Stratus CS .
Dade Behring Sysmex Series Advanced D-Dimer ●
Diagnostica Stago Sta/Sta-R/Sta-Compact -- LIATEST ●
IL ACL Series ●
Roche Cobas Integra 400/800 Tina-quant ●
Roche Hitachi Tina-quant ●

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use	✓	or	Over-the Counter use
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(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K030182
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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.