UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA

K964270 · Universal Reagents, Inc. · GGP · Dec 18, 1996 · Hematology

Device Facts

• Record ID: K964270
• Device Name: UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
• Applicant: Universal Reagents, Inc.
• Product Code: GGP · Hematology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Indicated use - Factor deficient plasma, Factor - V 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 - V is human plasma immunodepleted of Factor V antigen. Used in clinical laboratories by technicians to perform quantitative clotting assays. Device serves as reagent to determine Factor V levels in patient plasma samples. Provides diagnostic information for congenital or acquired coagulation protein deficiencies. Product supplied frozen or lyophilized; compatible with various coagulation instruments and reagents per manufacturer instructions.

Clinical Evidence

Bench testing only. Performance verified by comparing assay results to known samples. Donors screened negative for HIV 1/2, HBsAG, HCV, and HIV-1ag. Factor deficiency confirmed at <1% with no inhibitors present.

Technological Characteristics

Human plasma immunodepleted of Factor V antigen; includes various buffers. Supplied frozen or lyophilized. Compatible with standard clinical coagulation instrumentation. No electronic or software components.

Indications for Use

Indicated for patients suspected of congenital or acquired Factor V deficiency. Used for quantitative determination of Factor V levels via clotting assay in clinical laboratories.

Predicate Devices

• Helena - Factor V (K792507)

Submission Summary (Full Text)

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UNIVERSAL REAGENTS, INC.
2858 North Pennsylvania Street
Indianapolis, Indiana 46205
PHONE: [phone]
FAX: [phone]
DEC 18 1996
K964270

# Non-Confidential Summary of Safety and Effectiveness

October 17, 1996
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 - V
**Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - V
**Classification Name:** Qualitative and Quantitative Factor Deficiency Test
**Intended device:** Factor deficient coagulation plasma - V
**Predicate devices:** Helena - K792507 - Factor V
**Device description:** Factor deficient plasma to be free of antigen of Factor V utilized in *in vitro* diagnostic use.

## Intended use:

Indicated use - Factor deficient plasma, Factor - V 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 | Helena |
| --- | --- | --- |
| 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 V deficient plasmas offered | Yes | Yes |

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page 4 of 32
# Non-Confidential Summary of Safety and Effectiveness (continued)

October 17, 1996

page 2 of 2

## Comparison to predicate devices: (continued)

| Attribute | Intended products | Helena |
| --- | --- | --- |
| Packaging either - Frozen or Dry / lyophilized | Yes | Yes |
| Can be used with different instruments and reagents per 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 HIV 1/2 and HBsAG | Yes | Yes |
| Negative by FDA approved test for HCV and HIV-1ag | Yes | not known |
| Donor criteria | | |
| Deficiency of relevant factor 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.