FACTOR DEFICIENT PLASMAS - FACTOR XI (11)

K972286 · Universal Reagents, Inc. · GJT · Jul 14, 1997 · Hematology

Device Facts

• Record ID: K972286
• Device Name: FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
• Applicant: Universal Reagents, Inc.
• Product Code: GJT · Hematology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

Factor deficient coagulation plasma - XI is human plasma immunodepleted of Factor XI; used in clinical laboratories for quantitative determination of Factor XI levels via clotting assay. Device assists in diagnosing patients suspected of congenital or acquired coagulation protein deficiencies. Product is provided frozen or lyophilized; compatible with various instruments and reagents per manufacturer instructions. Benefits include standardized testing for coagulation disorders. Safety profile includes testing negative for HIV 1/2, HBsAG, HCV, and HIV-1ag.

Clinical Evidence

Bench testing only. Performance verified by comparing assay results to known samples and confirming deficiency levels of relevant factor are less than 1%. Safety verified by negative results for HIV 1/2, HBsAG, HCV, and HIV-1ag using FDA-approved tests.

Technological Characteristics

Human plasma immunodepleted of Factor XI; contains various buffers. Provided in frozen or lyophilized form. Functions as a reagent for clotting assays. No specific software or electronic components.

Indications for Use

Indicated for quantitative determination of Factor XI levels in patients suspected of congenital or acquired Factor XI deficiency. Used in clinical laboratories.

Predicate Devices

• Pacific Hemostasis Factor XI (K# unknown)

Submission Summary (Full Text)

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K972286

JUL 14 1997

#### Safety and Effectiveness Summary and Premarket Notification Truthful and Accurate Statement

## Safety and effectiveness summary:

Section # 2

The Non-confidential Summary of Safety and Effectiveness follows.

### Premarket Notification Truthful and Accurate Statement:

As recommended, this statement has been placed on company letterhead and follows.

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Image /page/1/Picture/0 description: The image is a black and white drawing of a world map. The map is drawn in a unique projection, where the continents are stretched and distorted. The map is also overlaid with a grid of lines, which may represent latitude and longitude. The continents are recognizable, but their shapes are not accurate.

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

1. . . . .

#### Non-Confidential Summary of Safety and Effectiveness June 18, 1997 page 1 of 2

| Universal Reagents, Inc.<br>2858 N. Pennsylvania St.<br>Indianapolis, IN 46205 | Tel - [phone]<br>Fax - [phone] |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Official contact: | Jorge Miller, Director, Coagulation Products |
| Proprietary or Trade Name: | Factor deficient coagulation plasma - XI |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - XI |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - XI |
| Predicate devices: | Pacific Hemostasis Factor XI - K# unknown |
| Device description: | Factor deficient plasma to be free of antigen of Factor XI<br>utilized in in vitro diagnostic use. |

#### Intended use:

Indicated use - Factor deficient plasma, Factor - XI is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in 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<br>of coagulation of plasma | Yes | Yes |
| In vitro diagnostic use | Yes | Yes |
| Used as a quantitative assay | Yes | Yes |
| Design | | |
| Factor XI deficient plasma offered | Yes | Yes |
| page 3 of 30 | | |

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# Non-Confidential Summary of Safety and Effectiveness

June 18, 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

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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JUL 1 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K972286 Re : URI Factor XI Requlatory Class: II Product Code: GJT, GGP Dated: June 18, 1997 Received: June 19, 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 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 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 diaqnostic 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 one roganieren one instion" (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)

page 1 of 1

#### 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 Factor - XI (11)

Indications for Use:

This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.

> Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

Claims -Negative per FDA approved test for HIV 1/2, HBsAG, HCV, HIV-1ag · Packaging -Frozen

Freeze dried - Lyophilized

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices
510(k) Number 7-60-92

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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ttachments