PROC APC ASSAY, PROC CONTROL PLASMA

K962968 · Behring Diagnostics, Inc. · GGP · Dec 13, 1996 · Hematology

Device Facts

• Record ID: K962968
• Device Name: PROC APC ASSAY, PROC CONTROL PLASMA
• Applicant: Behring Diagnostics, Inc.
• Product Code: GGP · Hematology
• Decision Date: Dec 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

ProC APC is intended for the determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma.

Device Story

ProC APC assay; in vitro diagnostic reagent kit. Inputs: citrated human plasma samples. Principle: measures activated partial thromboplastin time (aPTT) in presence and absence of activated Protein C. Components: liquid aPTT reagent (phospholipids, silica activator), lyophilized activated Protein C reagent, lyophilized control plasma. Used in clinical laboratory settings by trained technicians. Output: quantitative/qualitative assessment of APC sensitivity. Clinical utility: aids in identifying Factor V Leiden carriers or abnormal APC sensitivity states; supports coagulation disorder diagnosis.

Clinical Evidence

Comparative study of 116 plasma samples (22 Factor V Leiden carriers, 94 normal donors) against predicate. ProC APC correctly identified all 116 samples. Precision studies per NCCLS EP5: within-run precision 1.7-2.9%; total precision 2.5-7.3%.

Technological Characteristics

In vitro diagnostic reagent kit. Components: liquid aPTT reagent (phospholipids, silica-based activator), lyophilized activated Protein C reagent, lyophilized control plasma. Manual or automated coagulation analyzer compatible. No software or electronic components.

Indications for Use

Indicated for the determination of activated Protein C sensitivity in citrated human plasma to assess for Factor V Leiden or other causes of abnormal APC sensitivity.

Predicate Devices

• Chromogenix Coatest APC Resistance-C

Submission Summary (Full Text)

{0}

KAC29G8
DEC 13 1996
BEHRING

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For ProC APC

## 1. Manufacturer and Contact Information:

**Manufacturer:** Behringwerke AG
Postfach 1140
35001 Marburg, Germany

**Contact Information:**
Paul Rogers
Behring Diagnostics Inc.
3403 Yerba Buena Road
P.O. Box 49013
San Jose, CA 95161-9013
Tel: [phone]

## 2. Device Classification Name:

The ProC APC is a Class II device and has a classification name of partial thromboplastin time test (21 CFR §864.7925).

## 3. Intended Use:

ProC APC is intended for the determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma.

## 4. Device Description and Characteristics:

The ProC APC assay consists of a liquid aPTT Reagent (containing phospholipids, silica-based activator), a lyophilized activated Protein C time (APCT) Reagent (containing activated human Protein C), and lyophilized Control Plasma (in the pathological range). This is similar to the Chromogenix Coatest APC Resistance-C (Coatest APC) assay, the predicate device, which consists a liquid aPTT reagent (phospholipids, silica-based activator), a lyophilized APC/CaCl2 reagent (activated human Protein C), and two lyophilized Control Plasmas (for normal and pathological ranges).

**Comparative Analysis:** A total of 116 plasma samples (22 Factor V Leiden carriers, 94 normal blood donors) were tested by the ProC APC and the Coatest APC Resistance-C. The ProC APC correctly identified the 116 samples as either having normal or abnormal (Factor V Leiden) APC sensitivities. The Coatest APC identified 20 of the 22 Factor V Leiden samples as having abnormal APC sensitivities and 92 of the 94 normal blood donor samples as having normal APC sensitivities.

**Precision:** Precision studies were performed following the NCCLS EP5 guideline using two plasma samples which were in the normal and abnormal APC sensitivity ranges. The within-run precision ranged from 1.7 to 2.9%. The total precision ranged from 2.5 to 7.3%.

## 5. Substantial Equivalence:

Behring Diagnostics Inc. considers the ProC APC to be substantially equivalent to the Chromogenix Coatest APC Resistance-C in terms of intended use, reagent composition, and overall performance characteristics.

Syva® and Behring
diagnostic products