FACTOR DEFICIENT PLASMA

K961929 · Universal Reagents, Inc. · GGP · Oct 10, 1996 · Hematology

Device Facts

• Record ID: K961929
• Device Name: FACTOR DEFICIENT PLASMA
• Applicant: Universal Reagents, Inc.
• Product Code: GGP · Hematology
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, X, XI, XII, 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. Factor VIII is human plasma and bovine material.

Device Story

Factor deficient coagulation plasmas are human plasma products immunodepleted of specific coagulation factors (II, V, VII, VIII, IX, X, XI, XII). Used in hospital and clinical laboratories by laboratory personnel to perform quantitative clotting assays. The device serves as a reagent to determine specific factor levels in patient plasma samples. By comparing patient clotting times against assays using these deficient plasmas, clinicians identify congenital or acquired factor deficiencies. Factor VIII product includes bovine material. Products are provided frozen or lyophilized.

Clinical Evidence

Bench testing only. Performance verified by comparing assay results to known samples. Donor criteria include factor deficiency levels <1%, absence of inhibitors, and negative testing for HIV 1/2, HBsAG, HCV, and HIV-1ag.

Technological Characteristics

Human plasma immunodepleted of specific coagulation factors (II, V, VII, VIII, IX, X, XI, XII). Factor VIII contains bovine material. Supplied as frozen or lyophilized. Includes various buffers. Compatible with standard coagulation instrumentation.

Indications for Use

Indicated for quantitative determination of specific coagulation factor levels (II, V, VII, VIII, IX, X, XI, XII) in patients suspected of congenital or acquired coagulation protein deficiencies.

Predicate Devices

• Behring Factor Deficient Plasmas (K924394, K924396, K924400)
• Medical Diagnostics Technologies Factor Deficient Plasmas (K893523, K893524, K893525, K893533, K893534, K893535, K893536, K900133)

Submission Summary (Full Text)

{0}

UNIVERSAL REAGENTS, INC.
2858 North Pennsylvania Street
Indianapolis, Indiana 46205
PHONE: [phone]
FAX: [phone]
OCT 10 1996
K961929

# Non-Confidential Summary of Safety and Effectiveness

May 15, 1996
page 1 of 3

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 - II, V, VII, VIII, IX, X, XI, XII

**Common/Usual Name:** Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII

**Classification Name:** Factor deficient coagulation plasma

**Intended device:** Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII

**Predicate devices:**

Behring Factor Deficient Plasmas -
K924394 - Factor V, K924396 - Factor VIII, IX, XI, XII
K924400 - Factor II, VII, X

and

Medical Diagnostics Technologies -
K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XII, K893535 - Factor VII, K893536 - Factor XI, K900133 - Factor II.

**Device description:** Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XII, XII, respectively, utilized in *in vitro* diagnostic use.

**Intended use:**

Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, X, XI, XII, 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. Factor VIII is human plasma and bovine material.

**Environment of use -** Hospital, laboratories

page 3 of 25

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page 4 of 25
# Non-Confidential Summary of Safety and Effectiveness (continued)

May 15, 1996
page 2 of 3

## Comparison to predicate devices: (continued)

| Attribute | Intended products | Behring | Medical Diagnostics Technologies |
| --- | --- | --- | --- |
| Use | | | |
| Indicated for use in determination of coagulation of plasma | Yes | Yes | Yes |
| In vitro diagnostic use | Yes | Yes | Yes |
| Used as a quantitative assay | Yes | Yes | Yes |
| Design | | | |
| Factor deficient plasmas offered - II, V, VII, VIII, IX, X, XI, XII | Yes | Yes | Yes |
| Packaging either - Frozen or Dry / lyophilized | Yes | Yes | Yes |
| Can be used with different instruments and reagents per manufacturer instructions | Yes | Yes | Yes |
| Materials | | | |
| Donor human plasma | Yes | Yes | Yes |
| Bovine enhanced factor VIII | Yes | Yes | Yes |
| Various buffers | Yes | Yes | Yes |
| Performance Testing | | | |
| Compare assay to known sample | Yes | Yes | Yes |
| Negative by FDA approved test for HIV 1/2 and HBsAG | Yes | Yes | Yes |

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page 5 of 25
# Non-Confidential Summary of Safety and Effectiveness (continued)

May 15, 1996
page 3 of 3

## Comparison to predicate devices: (continued)

| Attribute | Intended products | Behring | Medical Diagnostics Technologies |
| --- | --- | --- | --- |
| Performance Testing (continued) | | | |
| Negative by FDA approved test for HCV and HIV-1ag | Yes | not known | not known |
| Donor criteria | | | |
| Deficiency of relevant factor less than 1% | Yes | not know | Yes |
| Negative for HIV and HBsAG | Yes | Yes | Yes |
| Negative for HCV, HIV-1ag | Yes | not known | not known |
| No inhibitor present | Yes | not known | Yes |

## B. Differences

The only difference is that the intended products are claimed to be negative for HCV and HIV-1ag by an FDA approved test.

Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.