Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Device Description

Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.

AI/ML Overview

This submission focuses on a control material used for in-vitro diagnostic tests, rather than an AI/ML device that would typically generate performance metrics like sensitivity, specificity, or AUC. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device: Biopool International LA Positive Control Plasma, Cat. No. 50113 (K961370)	The safety and effectiveness of Sigma ACCUTROL™ LA Control, Cat. No. A3345, has been demonstrated by its substantial equivalence to the Biopool International LA Positive Control Plasma, Cat. No. 50113, (K961370).
Stable for 48 hours when stored at 2-8°C after reconstitution.	After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C.
Stable for 4 weeks when stored at -20°C after reconstitution.	After reconstitution with water, ACCUTROL™ LA Control is stable for 4 weeks when stored at -20°C.
Suitable for use as a positive control for lupus anticoagulant testing (APTT and dRVVT).	Sigma Diagnostics ACCUTROL™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT).

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

Sample Size: Not explicitly stated for specific test sets. The submission relies on demonstrating substantial equivalence to a predicate device, which implies that the performance characteristics were compared against established parameters of the predicate, rather than an independent "test set" in the context of an AI/ML diagnostic.
Data Provenance: Not specified. As a human plasma control, the source of the plasma itself (e.g., country of origin) is not detailed in the provided summary. The data presented is for the characterization of the control material (stability, intended use) to demonstrate equivalence.

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

This is not applicable as this is a control material for in-vitro diagnostic tests, not a device requiring expert interpretation for ground truth establishment. The effectiveness is determined by its behavior as a control in laboratory assays, which have their own established validation procedures.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

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 an in-vitro diagnostic control material, not an AI/ML diagnostic tool.

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

Not applicable. This is an in-vitro diagnostic control material.

7. The type of ground truth used

The "ground truth" for this device is its performance characteristics as a control material, primarily its ability to mimic a positive sample for lupus anticoagulant testing and its stability. This is established through laboratory experiments and comparison to a legally marketed predicate device with established performance. The "ground truth" here refers to the expected behavior and stability of the control plasma itself, not a diagnosis for a patient.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that conventional sense. The product development would involve manufacturing and quality control batches, but these are not analogous to training data for an algorithm.

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

Not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

FEB 0 6 2002

KD 20109

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ACCUTROL™ LA Control, Cat. No. A3345

Sigma Diagnostics ACCUTROL™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT)

The safety and effectiveness of the Sigma ACCUTROL™ LA Control, Cat. No. A3345) has been demonstrated by its substantial equivalence to the Biopool International LA Positive Control Plasma, Cat. No. 50113, (K961370).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the department's name encircling an abstract image. The abstract image resembles an eagle or bird-like figure with three stylized wings or feathers. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics, Inc. 545 South Ewing Avenue St. Louis, Missouri 63103

FEB 0 6 2002

K020109 Re:

Trade/Device Name: Sigma Diagnostics ACCUCLOT™ LA Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGC Dated: January 9, 2002 Received: January 11, 2002

Dear Dr. Gilbert:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

{3}------------------------------------------------

510(k) Number (if known):

Device Name: _Sigma Diagnostics ACCUCLOT™ LA Control _

Indications For Use:

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K020109

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

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.