UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA

K964459 · Universal Reagents, Inc. · GGP · Dec 18, 1996 · Hematology

Device Facts

• Record ID: K964459
• Device Name: UNIVERSAL REAGENT FACTOR X 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

Factor deficient plasma, Factor - X 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 - X is human plasma immunodepleted of Factor X; used in clinical laboratories for in vitro diagnostic quantitative determination of Factor X levels via clotting assay. Device aids diagnosis of congenital or acquired Factor X deficiency. Product supplied frozen or lyophilized; used with various instruments and reagents per manufacturer instructions. Safety profile includes donor screening negative for HIV 1/2, HBsAG, HCV, and HIV-1ag, with factor deficiency <1% and no inhibitors present.

Clinical Evidence

Bench testing only; performance verified by comparing assay results to known samples.

Technological Characteristics

Human plasma immunodepleted of Factor X; contains various buffers. Supplied frozen or lyophilized. Compatible with various coagulation instruments and reagents. No software or electronic components.

Indications for Use

Indicated for patients suspected of congenital or acquired deficiency of Factor X coagulation protein.

Predicate Devices

• Sigma - Factor X (K843310)

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

# Non-Confidential Summary of Safety and Effectiveness

November 1, 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 - X
**Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - X
**Classification Name:** Qualitative and Quantitative Factor Deficiency Test
**Intended device:** Factor deficient coagulation plasma - X
**Predicate devices:** Sigma - K843310 - Factor X
**Device description:** Factor deficient plasma to be free of antigen of Factor X utilized in *in vitro* diagnostic use.

**Intended use:**

Indicated use - Factor deficient plasma, Factor - X 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 | Sigma |
| --- | --- | --- |
| 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 |

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

November 1, 1996

page 2 of 2

## Comparison to predicate devices: (continued)

| Attribute | Intended products | Sigma |
| --- | --- | --- |
| Design | | |
| 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.