The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

Device Description

The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

AI/ML Overview

The provided text is a 510(k) summary for a control plasma device (STA® - Control LA 1+2), not a diagnostic algorithm or AI-powered device. Therefore, much of the requested information (like AI performance metrics, training/test sets, expert adjudication, MRMC studies) is not applicable to this submission.

However, I can extract the relevant information regarding the device's intended use and the general nature of its "performance" as a control product.

Device: STA® - Control LA 1+2 (Lupus Control Plasmas)

1. A table of acceptance criteria and the reported device performance

For a control plasma, the "acceptance criteria" generally involve demonstrating that the control material performs as expected (LA positive and LA negative) when tested with the specified diagnostic assays and that it is substantially equivalent to a predicate device. The performance is typically assessed by its reactivity in the target assays.

Acceptance Criteria (Implied)	Reported Device Performance
Provides LA-negative control plasma that tests negative with specified LA detection kits.	The device provides an LA-negative plasma intended for quality control of LA testing using STA® -Staclot® dRVV Screen, STA® -Staclot® dRVV Confirm, and Staclot® LA kits. (The document implies this functionality based on its description and intended use, but specific numerical performance data like expected ranges or negativity rates are not provided in this summary.)
Provides LA-positive control plasma that tests positive with specified LA detection kits.	The device provides an LA-positive plasma intended for quality control of LA testing using STA® -Staclot® dRVV Screen, STA® -Staclot® dRVV Confirm, and Staclot® LA kits. (Similar to the LA-negative control, specific numerical performance data like expected ranges or positivity rates are not provided in this summary, but its function as a positive control is stated.)
Substantial Equivalence to Predicate Device	The FDA reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate device, Cryocheck Lupus Positive Control (K952623). This implies that the performance characteristics, intended use, and technological characteristics are similar enough to the predicate that it performs as intended for its stated quality control purpose. (Specific comparative performance data is not included in this 510(k) summary).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a control material, "test set" would typically refer to the various batches of the control manufactured and tested, or the number of runs/analyses performed to establish its characteristics and lot-to-lot consistency. The summary does not disclose the specifics of these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a control material for laboratory tests, not a diagnostic or AI algorithm requiring expert adjudication of ground truth for patient data. Its "ground truth" is defined by its known formulation (LA positive vs. LA negative) and its reactivity with specific diagnostic assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As explained above, this device does not involve human interpretation of medical images or data that would necessitate an adjudication method for a test set.

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

This information is not applicable and not provided. This is not an AI-powered device or a diagnostic tool that involves human readers.

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

This information is not applicable and not provided. This device is a control material, not an algorithm.

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

For this control device, the "ground truth" is its known composition as either LA-positive or LA-negative plasma, and its established reactivity when tested with specific Lupus Anticoagulant detection kits. It is a manufactured reagent designed to elicit a specific, known response.

8. The sample size for the training set

This information is not applicable and not provided. This device is a manufactured control plasma, not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. As above, there is no "training set" for this product in the AI context.

Summary

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K061803

JUL 2 8 2006

Diagnostica Stago Inc. STA® - Control LA 1+2 510K Summary

11) 510K Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: -----------------------------------------------------------------------------------------------------------------------------------------------

a) Applicant Name and Address

Applicant:	Diagnostica Stago, Inc.
Address:	5 Century Drive
	Parsippany, NJ 07054
Contact Person:	Melissa Cole
Phone #:	800-222-2624, x 4416
Fax #:	973-631-1618
E-mail:	Melissa.Cole@stago-us.com
Date of Preparation:	June 22, 2006

b) Device Name

Trade Name:	STA® - Control LA 1+2
Common Name:	Lupus Control Plasmas
Classification Name:	Plasma, Control, Normal & Abnormal

c) Predicate Device

Cryocheck Lupus Positive Control (K952623) manufactured by Precision Biologic, Inc. Dartmouth, Nova Scotia, Canada.

d) Intended Use/Device Description

The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits:

STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

e) Technological Characteristic Summary

STA® - Control LA 1+2 and Cryocheck Lupus Positive Control are human citrated plasmas intended for control of Lupus Anticoagulant testing (i.e. DRVVT and Staclot LA).

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DEPARTMENT OF HEALTH & HI MAN SERVICES

Public Feath Service

Food and Drug Aomin stration 2098 Garther Road Воскивае МО 20850

Laura A. Worfolk, Ph.D. Acting Director. Quality Control and Regulatory Affairs Diagnostica Stago, Inc. Five Century Drive Parsippany. New Jersey 07054

JUL 28 2006

Re: K061803 Trade/Device Name: STA®- Control LA 1+2 Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Control, Normal & Abnormal Regulatory Class: II Product Code: GGC, GGN Dated: June 23, 2006 Received: June 27, 2006

Dear Dr. Worfolk:

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). 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.

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Page 2 -

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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: STA 8 - Control LA 1+2

Indications for Use:

STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Page

See Device

510(k) K061803

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.