(316 days)
Not Found
No
The summary describes a chromogenic assay kit for measuring protein C activity. There is no mention of AI, ML, or any computational analysis beyond standard laboratory measurements and statistical analysis (CV%). The presence of "automated method" refers to the use of automated laboratory equipment, not AI/ML.
No
The device is described as a chromogenic assay for measuring protein C activity in human plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is a chromogenic assay for measuring Protein C Activity in human plasma, which is a diagnostic measurement.
No
The device description explicitly states it is a "chromogenic assay consisting of chromogenic substrate and Protein C activator," which are physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for "measuring the Protein C Activity in human citrated plasma." This indicates that the device is used to examine specimens derived from the human body (plasma) to provide information for diagnostic purposes.
- Device Description: The device is a "chromogenic assay consisting of chromogenic substrate and Protein C activator." This describes a reagent-based test used to perform a chemical reaction on a biological sample.
- Performance Studies: The document includes performance data (Intra-Assay CV% and Inter-Assay CV%) which are typical metrics for evaluating the performance of diagnostic assays.
- Predicate Device: The mention of a predicate device (K922201; Coamatic Protein C) which is also likely an IVD, further supports the classification of this device as an IVD.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits this description by measuring a specific analyte (Protein C Activity) in a human sample for potential diagnostic purposes related to blood clotting disorders.
N/A
Intended Use / Indications for Use
Biophen Protein C is intended for use as a chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Biophen ProteinC kit is intended for measuring the Protein C Activity in human plasma by chromogenic assay using a manual or an automated method.
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Product codes
GGP
Device Description
Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
Biophen Protein C kit consists of:
c. Protac®:
d. SaPC-21 Substrate
Reagent 1 (Protac®): This is highly purified enzyme, extracted from the Agkistrodom C Contortrix snake venom, lyophilized and stabilized, able to specifically activate protein C
Reagent 2 (SaPC-21 Substrate):Chromogenic substrate, lyophilized and specific for Protein C Sequence: p-Glu-Pro-Arg-pNa.HCl Purity: 95% Molecular weight: 502.5Kd Free pNa: 0.0%
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following table shows the performance of the device.
| Sample | Protein C Concentration% | Intra-Assay CV% | InterAssay CV% | N | ||
|---|---|---|---|---|---|---|
| Sample 1 | 0.37 | 1.26 | 12 | |||
| Sample 2 | 1.17 | 10 | 1.97 | 4 - | ||
| Sample 3 | 0.84 | 10 | 1.51 | 12 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
DEC 2 3 2005
510(K) Summary
Biophen Protein C 5 & 2.5
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
40503605 The assigned 510(k) number is
Fax#(+33) 1 34 48 72 36
Submitters name & Address: HyphenBiomed 155 Rue d' Eragny 95000 Neuville sur Oise, France Phone # (+33)1 34 40 65 10
Contact Name: ·
Dr. Jean Amiral Email: jamiral@Hyphen-Biomed
Preparation date: 18th Nov 2004
Device name & Classification: Test, qualitative and quantitative factor deficiency
Class: Il
Product Code: GGP
Regulation number: 864.7290
Predicate device name: Coamatic Protein C
Manufacturer of Predicate device:
Chromogenix AB/Instrumentation Laboratory Taljegardsgatan 3 S-431 53 MoIndal Sweden. SW
Device Description: Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
Device Intended Use: Biophen Protein C is intended for use as a chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Performance of the Device:
The following table shows the performance of the device.
| Sample | Protein C
Concentration% | Intra-
Assay
CV% | | Inter
Assay
CV% | N | |
|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----|-----------------------|-----|--|
| Sample 1 | તે જેવી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય | 0.37 | | 1.26 | 12 | |
| Sample 2 | રેત્રે | 1.17 | 10 | 1.97 | 4 - | |
| Sample 3 | રેવે | 0.84 | 10 | 1.51 | 12 | |
Comments on substantial equivalence:
Biophen Protein C is substantially equivalent to Coamatic Protein C (K922201), manufactured by Chromogenix AB, and currently marketed in the United states by Instrumentation laboratory; this is based on the following similarities:
Hyphen-Biomed 510(k) for Biophen Protein C 5 & 2.5
1
- Both products are intended for use in the quantitative determination of Protein C 1. activity in citrated human plasma.
- Both the device uses similar reagents ( protein activator and substrate) 2.
- The reagents used in both the device are in lyophilized form and reconstituted in నే. distilled water.
- Both devices produce results in % activity of protein C. 4.
The following table shows comparison table of Biophen Protein C and its predicate device.
2
| Biophen Protein C | Coamatic® Protein C (K922201) | |
|---|---|---|
| Intended Use | Biophen ProteinC kit is intended for measuring the Protein C Activity in human plasma by chromogenic assay using a manual or an automated method. | Coamatic Protein C is intended for use as a chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma. |
| Indication for Use | Biophen ProteinC kit is intended for measuring the Protein C Activity in human plasma by chromogenic assay using a manual or an automated method. | Coamatic Protein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma. |
| Material | Biophen Protein C kit consists of: | |
| c. Protac®: | ||
| d. SaPC-21 Substrate | ||
| Reagent 1 (Protac®): This is highly purified enzyme, extracted from the Agkistrodom C Contortrix snake venom, lyophilized and stabilized, able to specifically activate protein C | ||
| Reagent 2 (SaPC-21 Substrate):Chromogenic substrate, lyophilized and specific for Protein C | ||
| Sequence: p-Glu-Pro-Arg-pNa.HCl | ||
| Purity: 95% | ||
| Molecular weight: 502.5Kd | ||
| Free pNa: 0.0% | Coamatic protein C kit consists of: |
- Protein C activator
- Substrate S-2366
Reagent 1 (Protein C activator): Lyophilized venom enzyme with bovine serum albumin(stabilizer) and Ciprofloxacin( preservative) from southern copperhead snake manufactured by Agkistrodom C Contortrix.
Reagent 2( S-2366): Lyophilized chromogenic substrate pyroGlu-Pro-Arg-PNA-HCl. |
| Format Matrix | Lyophilized
Reagent 1: Protac® in distilled water matrix
Reagent 2: SaPC-21 Substrate in distilled water matrix | Lyophilized
Reagent 1: Protein C activator in distilled water matrix
Reagent 2: S-2366 Substrate in distilled water matrix |
| Analytes | Protein C activity | Protein C activity |
Comparison of Biophen Protein C & Coamatic® Protein C devices
Hyphen-Biomed
510(k) for Biophen Protein C 5 & 2.5
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Hyphen Biomed c/o Mr. Ola Anderson US Agent, Aniara 6560 Gove Ct. Mason, OH 45040
DEC 2 3 2005
Re: K050365
Trade/Device Name: Biophen Protein C 5 and 2.5 Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: February 14, 2005 Received: February 15, 2005
Dear Mr. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(K) prematics by equivalent (for the indications for the indications for referenced above and have determined in a devices marketed in interstate commerce
use stated in the enclosure) to legally mark to Madical Dovices that use stated in the enclosure) to legally that keep proce Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Medical Food Drug, and Cosmetic prior to May 28, 1976, the enactment date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food. You may. have been reclassified in accordance with the provisions of as application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (PMA). Act (Act) that do not require approval or a premater approval of the Act. The general
therefore, market the device, subject to the general controls provisions of the Act. T therefore, market the device, subject to the general onlines provision, listing of devices, good
controls provisions of the Act include requirements for annual registration, controls provisions of the Act mende requirements for and adulteration.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Crass in (eregulations affecting your device can be
may be subject to such additional controls. Existing may In addition FD may be subject to such additional controls. Existilizations found in the Code of I ederal resgances in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issualice of a substance onlines with other requirements of the Act of
that FDA has made a determination that your device complies with other co that FDA has made a determination that your uce the other Federal agencies. You must comply with
any Federal statutes and regulations administered by other Federal of J CFR any Federal statutes and regulations administered of the registration and listing (21 CFR Pat 807);
all the Act's requirements, including, but not limited to: registration an all the Act's requirements, Including, pur nor innice corrective requirements as set forth in the quality labeling (21 CFR Part 801), good manufacturing production, the electronic product radiation
systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic produ systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legally This letter will allow you to begin marketing of substantial equivalence of your device to legally premarket notification. The FDA Inding of substantial equivalities of your device to
marketed predicate device results in a classification for your device and thus, permits y proceed to the market.
4
Page 2 --
If you desire specific information about the application of labeling requirements to your device, places contact the Office of In If you desire specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, a lease note or questions on the promotion and advertising of 75-0484 . Also, please note the Vitro Diagnostic Device Evaluation and Sales and Sales of Cification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notifications the Act f regulation entitled, "Misoranding by reichers on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-Division of Sinan Prairier and its Internet address (800) 056-2041 of (501) " (501) " " (501) " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ূর্তি50365
Device Name: _Biophen ® Protein C 2.5 & 5
Indications for Use:
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in
ternation in the more waing a monual or an automated method. Biophen Protein C 5 & 2.5 Kit is a Onromogonis assay as a
human citrated plasma using a manual or an automated method.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ia chan for
Josephine Bautista
Division Sign-Off
Office of in Vitro Dlagnostic valuation and safety
510(k) K050361