UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA

K973143 · Universal Reagents, Inc. · GGP · Sep 25, 1997 · Hematology

Device Facts

• Record ID: K973143
• Device Name: UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
• Applicant: Universal Reagents, Inc.
• Product Code: GGP · Hematology
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

Indicated use - Factor deficient plasma, Factor - XII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Device Story

Factor XII deficient plasma is human plasma immunodepleted of Factor XII; contains normal levels of other coagulation factors. Used in clinical laboratories by technicians/pathologists to perform quantitative clotting assays. Input is patient plasma sample; device acts as reagent to isolate Factor XII activity. Output is quantitative factor level measurement. Clinical utility involves diagnosing congenital or acquired Factor XII deficiency. Benefits include standardized diagnostic testing for coagulation disorders.

Clinical Evidence

No clinical data. Performance established via bench testing comparing assay results to known samples and verifying negative status for HIV 1/2, HBsAG, HCV, and HIV-1ag using FDA-approved tests.

Technological Characteristics

Human plasma immunodepleted of Factor XII; contains various buffers. Available as frozen or lyophilized. Used in standard clinical laboratory clotting assays. No electronic or software components.

Indications for Use

Indicated for patients suspected of congenital or acquired Factor XII deficiency. Used for quantitative determination of Factor XII levels via clotting assay.

Predicate Devices

• Pacific Hemostasis Factor XII (K# unknown)

Submission Summary (Full Text)

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### UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: [phone] FAX: [phone]

K973143

# SEP 2 5 1997

#### Non-Confidential Summary of Safety and Effectiveness August 21, 1997 page 1 of 2

Universal Reagents, Inc. 2858 N. Pennsylvania St. Indianapolis, IN 46205

# Tel - [phone]
Fax - [phone]

| Official contact: | Jorge Miller, Director, Coagulation Products |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Factor deficient coagulation plasma - XII |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - XII |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - XII |
| Predicate devices: | Pacific Hemostasis Factor XII - K# unknown |
| Device description: | Factor deficient plasma to be free of antigen of Factor XII<br>utilized in in vitro diagnostic use. |

Intended use:

Indicated use - Factor deficient plasma, Factor - XII is a human plasma immunodepleted of the
specific factor and intended for use in the quantitative determination of the patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

| Environment of use: | Clinical laboratories | |
|-------------------------------------------------------------|-----------------------|--------------------|
| Comparison to predicate devices: | | |
| Attribute | Intended product | Pacific Hemostasis |
| Use | | |
| Indicated for use in determination of coagulation of plasma | Yes | Yes |
| In vitro diagnostic use | Yes | Yes |
| Used as a quantitative assay | Yes | Yes |
| Design | | |
| Factor XII deficient plasma offered | Yes | Yes |
| page 3 of 36 | | |

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# Non-Confidential Summary of Safety and Effectiveness

# August 21, 1997

### page 2 of 2

## Comparison to predicate devices: (continued)

| Attribute | Intended<br>product | Pacific Hemostasis |
|-----------------------------------------------------------------------------------------|---------------------|--------------------|
| Packaging either -<br>Frozen or Dry / lyophilized | Yes | Yes |
| Can be used with different<br>instruments and reagents per<br>manufacturer instructions | Yes | Yes |
| Materials | | |
| Donor human plasma | Yes | Yes |
| Various buffers | Yes | Yes |
| Performance Testing | | |
| Compare assay to known sample | Yes | Yes |
| Negative by FDA approved test for<br>HIV 1/2 and HBsAG | Yes | Yes |
| Negative by FDA approved test for<br>HCV and HIV-1ag | Yes | not known |
| Deficiency of relevant factor<br>less than 1% | Yes | not known |
| Negative for HIV and HBsAG | Yes | Yes |
| Negative for HCV, HIV-1ag | Yes | not known |
| No inhibitor present | Yes | not known |

#### Differences

r

The only difference is that the intended product is claimed to be negative for HCV and HIV-1ag by an FDA approved test.

Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 5 1997

Jorge Miller Director, Coaqulation Products Universal Reagents, Inc. 2858 North Pennsylvania Street Indianapolis, Indiana 46205

Re : K973143 URI Factor XII Requlatory Class: II GJT, GGP Product Code: September 8, 1997 Dated: Received: September 15, 1997

Dear Mr. Miller:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ 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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2

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 requlation (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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Section # 3

# Labeling (continued)

# C. Indications for Use Statement

Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | (to be assigned) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Factor Deficient Coagulation Plasma<br>Factor - XII (12) |
| Indications for Use: | |
| Indicated use - | This product is intended for use in the quantitative determination of<br>factor levels in patients suspected of congenital or acquired deficiency<br>of this coagulation protein or factor, XII. |
| | Factor immunodeficient plasma XII is made from human plasma that<br>has been artificially depleted. This plasma has normal levels of all other<br>factors. |
| Claims - | Negative per FDA approved test for HIV 1/2, HBsAG, HCV, HIV-1ag |
| Packaging - | Frozen<br>Freeze dried - Lyophilized |

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number. 197343

Prescription Use (Per 21 CFR 801.109)

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