BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

{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<br>Concentration% | Intra-<br>Assay<br>CV% | | Inter<br>Assay<br>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:<br>c. Protac®:<br>d. SaPC-21 Substrate<br>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<br>Reagent 2 (SaPC-21 Substrate):Chromogenic substrate, lyophilized and specific for Protein C<br>Sequence: p-Glu-Pro-Arg-pNa.HCl<br>Purity: 95%<br>Molecular weight: 502.5Kd<br>Free pNa: 0.0% | Coamatic protein C kit consists of:<br>3. Protein C activator<br>4. Substrate S-2366<br>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.<br>Reagent 2( S-2366): Lyophilized chromogenic substrate pyroGlu-Pro-Arg-PNA-HCl. | | Format Matrix | Lyophilized<br>Reagent 1: Protac® in distilled water matrix<br>Reagent 2: SaPC-21 Substrate in distilled water matrix | Lyophilized<br>Reagent 1: Protein C activator in distilled water matrix<br>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 - 112 -- {3}------------------------------------------------ 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