UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA

K970593 · Universal Reagents, Inc. · GJT · Apr 25, 1997 · Hematology

Device Facts

• Record ID: K970593
• Device Name: UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
• Applicant: Universal Reagents, Inc.
• Product Code: GJT · Hematology
• Decision Date: Apr 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Factor deficient plasma, Factor - VIII 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 - VIII is human plasma immunodepleted of Factor VIII antigen. Used in clinical laboratories by technicians to perform clotting assays for quantitative determination of Factor VIII levels. Device aids in diagnosing congenital or acquired coagulation protein deficiencies. Product supplied frozen or lyophilized; utilizes donor human plasma, enhanced bovine factor V, and buffers. Performance verified via assay comparison to known samples; safety ensured by 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. Safety validated by testing negative for HIV 1/2, HBsAG, HCV, and HIV-1ag using FDA-approved methods. Deficiency of Factor VIII confirmed at less than 1%.

Technological Characteristics

Human plasma immunodepleted of Factor VIII; contains enhanced bovine factor V and various buffers. Supplied in frozen or lyophilized form. Compatible with various coagulation instruments and reagents per manufacturer instructions.

Indications for Use

Indicated for quantitative determination of Factor VIII levels in patients suspected of congenital or acquired Factor VIII deficiency.

Predicate Devices

• OTC Factor VIII (K823453)

Submission Summary (Full Text)

{0}

UNIVERSAL REAGENTS, INC.
2858 North Pennsylvania Street
Indianapolis, Indiana 46205
PHONE: [phone]
FAX: [phone]
K970593
APR 25 1997

# Non-Confidential Summary of Safety and Effectiveness

February 17, 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 - VIII

**Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - VIII

**Classification Name:** Qualitative and Quantitative Factor Deficiency Test

**Intended device:** Factor deficient coagulation plasma - VIII

**Predicate devices:** OTC Factor VIII - K823453

**Device description:** Factor deficient plasma to be free of antigen of Factor VIII utilized in *in vitro* diagnostic use.

**Intended use:**

Indicated use - Factor deficient plasma, Factor - VIII 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 | OTC |
| --- | --- | --- |
| 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 VIII deficient plasma offered | Yes | Yes |

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page 4 of 36
# Non-Confidential Summary of Safety and Effectiveness (continued)

February 17, 1997

page 2 of 2

## Comparison to predicate devices: (continued)

| Attribute | Intended products | OTC |
| --- | --- | --- |
| 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 |
| Enhanced bovine factor V | 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 |
| 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.