SIGMA DIAGNOSTICS ACCUCLOT CONTROL I

K981248 · Sigma Diagnostics, Inc. · GGN · Apr 29, 1998 · Hematology

Device Facts

• Record ID: K981248
• Device Name: SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
• 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

Intended Use

Sigma Diagnostics ACCUCLOT™ CONTROL I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, in 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 I is a lyophilized human plasma-based product used as a normal control in coagulation laboratories. It is reconstituted with water and used to verify the accuracy and precision of coagulation assays, including PT, APTT, thrombin time, AT-III, and fibrinogen clotting methods. The control is processed alongside patient citrated plasma samples. Healthcare providers, such as laboratory technicians, use the control results to validate the performance of coagulation testing systems. By ensuring the assay is operating within expected parameters, the device helps maintain the reliability of patient coagulation test results, supporting clinical decision-making related to hemostasis and anticoagulation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human plasma-based product. Reconstituted with water. Stable for 48 hours at 2-8°C. In vitro diagnostic control.

Indications for Use

Indicated for use as a normal quality control material for coagulation testing in clinical laboratories, specifically for prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time, Antithrombin III (AT-III) assays, and fibrinogen determinations 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 I (Cat. No. 7916)

Submission Summary (Full Text)

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K981248

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR 2 9 1998 ACCUCLOTTM Control I, Cat. No. A4089

Sigma Diagnostics ACCUCLOT™ Control I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, 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 I has been demonstrated by its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level I (Cat. No. 7916). >>

Sigma Diagnostics ACCUCLOT™ Control I is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control I 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 Ewinq Avenue St. Louis, Missouri 63103

Re : K981248 ACCUCLOT™ Control I Regulatory Class: II Product Code: GIZ, 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. ਉੱ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Please note: concerning your device in the Federal Register. 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 regulations.

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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 Sitman

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 I

## Indications For Use:

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Sigma Diagnostics ACCUCLOT™ CONTROL I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, in 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divis Divis S10(k) J

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

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