UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA

K970607 · Universal Reagents, Inc. · GJT · Apr 25, 1997 · Hematology

Device Facts

• Record ID: K970607
• Device Name: UNIVERSAL REAGENT FACTOR VII 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

Indicated use - Factor deficient plasma, Factor - VII 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 - VII is human plasma immunodepleted of Factor VII; used in clinical laboratories for in vitro diagnostic testing. Device functions as a reagent in clotting assays to quantify Factor VII levels in patient plasma samples. Clinicians use results to diagnose or monitor congenital or acquired coagulation protein deficiencies. Product is provided in frozen or lyophilized form; compatible with various coagulation instruments and reagents per manufacturer instructions.

Clinical Evidence

Bench testing only. Performance verified by comparing assay results to known samples. Device confirmed to have <1% Factor VII activity and tested negative for HIV 1/2, HBsAG, HCV, and HIV-1ag using FDA-approved methods.

Technological Characteristics

Human plasma immunodepleted of Factor VII; includes various buffers. Form factor: frozen or lyophilized. Compatible with standard clinical coagulation instrumentation. No software or electronic components.

Indications for Use

Indicated for patients suspected of congenital or acquired Factor VII deficiency; used for quantitative determination of Factor VII levels via clotting assay.

Predicate Devices

• Ortho Diagnostic Systems - Factor VII (K883692)

Submission Summary (Full Text)

{0}

K970607
APR 25 1997

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

## 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 - VII
**Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - VII
**Classification Name:** Qualitative and Quantitative Factor Deficiency Test
**Intended device:** Factor deficient coagulation plasma - VII
**Predicate devices:** Ortho Diagnostic Systems - K883692 - Factor VII
**Device description:** Factor deficient plasma to be free of antigen of Factor VII utilized in *in vitro* diagnostic use.

**Intended use:**
Indicated use - Factor deficient plasma, Factor - VII 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 | Ortho |
| --- | --- | --- |
| 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 VII deficient plasma offered | Yes | Yes |

page 3 of 36

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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 | Ortho |
| --- | --- | --- |
| 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

| Attribute | Intended products | Ortho |
| --- | --- | --- |
| 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.