← Product Code [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP) · K962968 # PROC APC ASSAY, PROC CONTROL PLASMA (K962968) _Behring Diagnostics, Inc. · GGP · Dec 13, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K962968 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP.md) - **Decision Date:** Dec 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7290 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for 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. ## Predicate Devices - Chromogenix Coatest APC Resistance-C ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 408-239-2000 ## 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K962968](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K962968) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com