SIGMA DIAGNOSTICS ACCUCLOT CONTROL III

K981255 · Sigma Diagnostics, Inc. · GGN · Apr 29, 1998 · Hematology

Device Facts

• Record ID: K981255
• Device Name: SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
• Applicant: Sigma Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: Apr 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Sigma Diagnostics ACCUCLOT™ CONTROL III is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing

Device Story

ACCUCLOT™ Control III is a lyophilized human plasma-based product used as an abnormal control in coagulation laboratories. It serves as a quality control material for one-stage prothrombin time (PT), activated partial thromboplastin time (APTT), chromogenic Antithrombin III (AT-III) assays, and fibrinogen determinations via clotting methods. The product requires reconstitution with water and remains stable for 48 hours when stored at 2-8°C. It is intended for professional use by laboratory personnel to verify the accuracy and precision of coagulation testing systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human plasma-based control. Requires reconstitution with water. Stable for 48 hours at 2-8°C post-reconstitution. Class II device (Product Codes: GGC, GGN).

Indications for Use

Indicated for use as an abnormal quality control material for coagulation testing (PT, APTT, AT-III, and fibrinogen) in clinical laboratories using patient citrated plasma.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sigma Diagnostics Coagulation Control, Level III (Cat. No. 9916)

Submission Summary (Full Text)

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K9812JJ

## APR 2 9 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACCUCLOT™ Control III, Cat. No. A6089

Sigma Diagnostics ACCUCLOT™ Control III is a human plasma control that is suitable for use as a abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method.

The safety and effectiveness of the Sigma Diagnostics ACCUCLOT™ Control III has been demonstrated by its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level III (Cat. No. 9916).

Sigma Diagnostics ACCUCLOT™ Control III is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control III is stable for 48 hours when stored at 2-8°C.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 9 1998

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

K981255 Re : ACCUCLOT™ Control III Regulatory Class: II Product Code: GGC, GGN Dated: April 2, 1998 Received: April 6, 1998

Dear Dr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as-set --forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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): _

Device Name: Sigma Diagnostics ACCUCLOT™ CONTROL III_

## Indications For Use:

Sigma Diagnostics ACCUCLOT™ CONTROL III is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K981258 |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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