SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 by SIGMA DIAGNOSTICS, INC.

Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Device Description

Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay.
Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.

AI/ML Overview

This 510(k) summary describes a device that is a control solution for a diagnostic assay, not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable in this context.

However, I will extract and present the information that is relevant to the provided document.

Acceptance Criteria and Device Performance

This submission is for a control solution, and its "performance" is assessed by showing substantial equivalence to a previously cleared control solution. The primary acceptance criterion here is the demonstration of substantial equivalence.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (Sigma Diagnostics AUTO D-Dimer Control, Level 2, Cat. No. A5217, K003329)	The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A8096) has been demonstrated by its substantial equivalence to the predicate device.
Stability post-reconstitution	Stable for 3 days when stored at 2-8°C. Stable for 24 hours when stored at 18-26°C.

Study Details (Applicable Information)

Sample size used for the test set and the data provenance: Not applicable. This is a control solution, not a diagnostic device evaluated with patient samples in a traditional test set. The evaluation focuses on equivalence to another control product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant for a control solution's substantial equivalence review.
Adjudication method for the test set: Not applicable.
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/ML powered device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML powered device.
The type of ground truth used: For demonstrating substantial equivalence for a control solution, the "ground truth" implicitly refers to the established performance characteristics and intended use of the legally marketed predicate device. The comparison would be made against the predicate's known behavior in the specified assay.
The sample size for the training set: Not applicable. This is not an AI/ML powered device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 1 5 2001 AUTO D-Dimer Control, Level 2, Cat. No. A8096

K013544

The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A8096) has been demonstrated by its substantial equivalence to the Sigma Diagnostics AUTO D-Dimer Control, Level 2 (Cat. No. A5217, K003329).

Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with wavy lines extending from the bottom of the profiles.

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

NOV 1 5 2001

K013544 Re:

Trade Name: Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: II Product Code: DAP Dated: October 19, 2001 Received: October 24, 2001

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.

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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 nonthoution. The I Drivinessification 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 additionally 60711 . 1011 . 10 - questions on the promotion and advertising of your device, (201) 59 retect 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 miorination on Jour responser 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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510(k) Number (if known): _| 0135 44

NOV 1 5 2001 Device Name: _ Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Torphine Bautista

(Division Sigil-Off) Division of Climical Lationatory Siguiless 510(k) Number -

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).