SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

K013545 · Sigma Diagnostics, Inc. · DAP · Nov 15, 2001 · Hematology

Device Facts

• Record ID: K013545
• Device Name: SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
• Applicant: Sigma Diagnostics, Inc.
• Product Code: DAP · Hematology
• Decision Date: Nov 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Device Story

Device is lyophilized human plasma-based control; used in coagulation laboratories for quality control of Sigma Diagnostics AUTO D-dimer assays. Product requires reconstitution with water; stable for 3 days at 2-8°C or 24 hours at 18-26°C. Used by laboratory personnel to verify assay performance; ensures accuracy of patient citrated plasma testing. Provides elevated control values to monitor assay precision and reliability.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human plasma-based control; requires reconstitution with water. Stability: 3 days at 2-8°C or 24 hours at 18-26°C. Intended for use with Sigma Diagnostics AUTO D-dimer assay.

Indications for Use

Indicated for use as an abnormal quality control material in coagulation laboratories for the Sigma Diagnostics AUTO D-dimer assay using patient citrated plasma.

Predicate Devices

• Sigma Diagnostics AUTO D-Dimer Control, Level 2 (K003329)

Submission Summary (Full Text)

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# NOV 1 5 2001

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AUTO D-Dimer Control, Level 3, Cat. No. A8221

Image /page/0/Picture/2 description: The image shows text describing Sigma Diagnostics ACCUMARKTM AUTO D-Dimer Control, Level 3. It is a human plasma control suitable for use as an elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay. The text provides information about the product and its intended use. It is a control used in the Sigma Diagnostics AUTO D-dimer assay.

The safety and effectiveness of the Sigma Diagnostics AUTO D-Dimer Control, Level 3 (Cat. No. A8221) 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 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 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 seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

K013545 Re:

> Trade Name: Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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): ____________________________________________________________________________________________________________________________________________________

NOV 1 5 200.

Device Name: _Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3

#### Indications For Use: NOV 1 5 2001

Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma Olgina Diagnootion AS & Come as an abnormal control with patient citrated plasma in Dcontrol that is outlable for assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Devices sion of Clinical La 510(k) Number -

Image /page/3/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by a check mark. Below that, the text "(Per 21 CFR 801.109)" is printed in a smaller, regular font. The text indicates that the product is for prescription use only, as defined by the Code of Federal Regulations.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________