(136 days)
Chromogenix Coatest APC Resistance-C
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No
The summary describes a laboratory assay kit and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic (IVD) determination of activated Protein C sensitivity, which is a diagnostic function, not a therapeutic one.
Yes
This device is intended for the determination of APC sensitivity, which helps identify individuals with a predisposition to thrombosis, thus providing information useful for diagnosis.
No
The device description clearly states it consists of liquid and lyophilized reagents, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "determination of the activated Protein C sensitivity of the activated partial thromboplastin time (aPTT) in citrated human plasma." This involves testing a sample taken from the human body (plasma) outside of the body (in vitro) to provide information about a physiological state (activated Protein C sensitivity).
- Device Description: The description details reagents and control plasma used to perform a test on a biological sample.
- Performance Studies: The performance studies describe testing plasma samples and comparing the results to a predicate device, which is typical for IVD validation.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
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Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 (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%.
Key Metrics
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Predicate Device(s)
Chromogenix Coatest APC Resistance-C
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters that appear to be a combination of letters and numbers. The sequence starts with the letters 'Ka', followed by the number '6', and then the letters 'as'. The sequence ends with the numbers '968'. The handwriting is cursive and somewhat stylized, making it difficult to discern the exact characters.
DEC 1 3 1996
Image /page/0/Picture/2 description: The image shows a logo with the word "BEHRING" in bold, uppercase letters above a horizontal line. Below the line is a signature, presumably of someone named Behring, in cursive. The entire logo is contained within a rectangular box.
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.
Device Description and Characteristics: ব
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/CaC12 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 (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.