(213 days)
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No
The summary describes a chromogenic assay kit for quantitative determination of antithrombin and Protein C activity. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical components of the assay.
No
The device is described as an "in vitro chromogenic assay" for the quantitative determination of antithrombin and Protein C activity in citrated human plasma, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The device is described as an "in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma" and "Protein C activity in citrated human plasma," which are diagnostic measurements.
No
The device description explicitly states it is a "chromogenic assay consisting of a synthetic substrate and Protein C activator" and "a synthetic substrate, Factor Xa, and a Tris Heparin Buffer," indicating it is a chemical reagent kit, not software.
Yes, based on the provided information, both CHROMOPEP AT and CHROMOPEP PC are IVDs (In Vitro Diagnostics).
Here's why:
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Intended Use / Indications for Use: The intended use explicitly states that they are "in vitro chromogenic assay[s] for the quantitative determination of [substance] activity in citrated human plasma." The phrase "in vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs. They are used to analyze a sample taken from the human body (citrated human plasma) to provide diagnostic information.
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Device Description: The description of the devices as "chromogenic assay[s] consisting of..." further supports their nature as laboratory tests performed on biological samples.
Therefore, the intended use and device description clearly indicate that these devices are designed to be used outside of the human body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CHROMOPEP AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Product codes (comma separated list FDA assigned to the subject device)
GCP, JBQ
Device Description
Chromopep PC is a chromogenic assay consisting of a synthetic substrate and Protein C activator.
Chromopep AT is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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)
Not Found
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).
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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).
0
Premarket Notification [510(k)] Summary
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
The assigned 510(k) number is : K050498
- Horiba ABX Company: Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: February 16th, 2005
(a) Device Name:
| Trade/Proprietary Name: | Chromopep PC 2.5 or Chromopep PC 5 |
|---|---|
| Common or Usual Name: | Protein C chromogenic assay |
| Device Class | Class II |
| Classification Name: | Test, Quantitative factor deficiency (§864.7290) |
| Product Code: | GCP |
(b) Device Name:
| Trade/Proprietary Name: | Chromopep AT 2.5 or Chromopep AT 5 |
|---|---|
| Common or Usual Name: | Antithrombin chromogenic assay |
| Device Class | Class II |
| Classification Name: | Antithrombin quantitation (§864.7060) |
| Product Code: | JBQ |
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Substantial Equivalence:
Chromopep PC
The Chromopep PC is substantially equivalent to the predicate device Chromocheck Protein C of Precision BioLogic (K023990).
Chromopep AT
The Chromopep AT is substantially equivalent to the predicate device Chromocheck Antithrombin A T of Precision BioLogic (K023991).
Description:
Chromopep PC is a chromogenic assay consisting of a synthetic substrate and Protein C activator.
Chromopep AT is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer.
Intended Use :
Chromopep PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Chromopep AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
2
Determination of substantial equivalence :
| Parameter | Predicate device: | Device: |
|---|---|---|
| Device Name | Chromocheck Protein C | |
| (K023990) | Chromopep PC | |
| Intended Use | Test, quantitative factor deficiency | Test, Quantitative factor deficiency |
| Analytes | Protein C activity | Protein C activity |
| Component | ||
| Reagent | ||
| Matrices | Reagent 1 : Protein C activator in a distilled | |
| water matrix (0.65 IU) | ||
| Reagent 2 : Chromogenic substrate in a | ||
| distilled water matrix | Reagent 1 : Protein C activator in a | |
| distilled water matrix (0.65 IU) | ||
| Reagent 2 : Chromogenic substrate in a | ||
| distilled water matrix | ||
| Format | Lyophilized | Lyophilized |
| Packaging | Chromocheck Protein C 25 | |
| 4 x Protein C Activator (0.65IU) | ||
| 4 x Substrate (4mg) | ||
| (Reconstituted volume - 2.5ml) |
Chromocheck Protein C 50
4 x Protein C Activator (1.30IU)
4 x Substrate (8mg)
(Reconstituted volume - 5.0ml) | Chromopep PC 2.5
4 x Protein C Activator (0.65IU)
4 x Substrate (4mg)
(Reconstituted volume - 2.5ml)
Chromopep PC 5
4 x Protein C Activator (1.30IU)
4 x Substrate (8mg)
(Reconstituted volume - 5.0ml) |
Table I : Comparison between Predicate Device & Chromopep PC
Table II : Comparison between Predicate Device & Chromopep AT
・・
| Parameter | Predicate device: | Device: |
|---|---|---|
| Device Name | Chromocheck Antithrombin | |
| (K023991) | Chromopep AT | |
| Intended Use | Antithrombin quantitation | Antithrombin quantitation |
| Analytes | Antithrombin | Antithrombin |
| Component | ||
| Reagent | ||
| Matrices | Reagent 1 : Factor Xa - Bovine Factor Xa | |
| in a Tris Heparin Buffer matrix | ||
| Reagent 2 : Chromogenic substrate in a | ||
| distilled water matrix | ||
| Reagent 3 : Tris Heparin Buffer | Reagent 1 : Factor Xa - Bovine Factor Xa | |
| in a Tris Heparin Buffer matrix | ||
| Reagent 2 : Chromogenic substrate in a | ||
| distilled water matrix | ||
| Reagent 3 : Tris Heparin Buffer | ||
| Format | Lyophilized | Lyophilized |
| Packaging | Chromocheck Antithrombin 25 | |
| 4 x Factor Xa (5µg) | ||
| 4 x Substrate (3.75mg) | ||
| 4 x 5mL Tris Heparin Buffer | ||
| Chromocheck Antithrombin 50 | ||
| 4 x Factor Xa (10µg) | ||
| 4 x Substrate (7.5mg) | ||
| 4 x 10mL Tris Heparin Buffer | Chromopep AT 2.5 | |
| 4 x Factor Xa (5µg) | ||
| 4 x Substrate (3.75mg) | ||
| 4 x 5mL Tris Heparin Buffer | ||
| Chromopep AT 5 | ||
| 4 x Factor Xa (10µg) | ||
| 4 x Substrate (7.5mg) | ||
| 4 x 10mL Tris Heparin Buffer |
3
Conclusions :
:
Chromopep PC can be considered as substantially equivalent to Chromocheck Protein C.
Chromopep AT can be considered as substantially equivalent to Chromocheck Antithrombin.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Tim Lawton Horiba ABX Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE
K050448 Re:
Roso Fro Chromopep AT 2.5 or Chromopep AT 5 Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP, JBQ Dated: September 2, 2005 Received: September 6, 2005
Dear Mr. Lawton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurrent the device is substantially equivalent (for the indications ferenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manat date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food and Food conninetee prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices fill have been reclasified in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen of the general controls provisions of the Act. The r ou may, therefore, market the do rees, color equirements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.
SEP 2 3 2005
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc abor of the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations wit may be subject to such additional connecess (CFR), Parts 800 to 895. In addition, FDA be found in This 21, 000vecements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri 3 issuation of a complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must or ally receral statutes and regularems and iding, but not limited to: registration and listing (21 Comply with an the Are 3 requirements 801 and 809); and good manufacturing practice CrK Part 807), labelling (21 CF CF Rate 607), and 2007, and 2007, This letter requirenchts as set form in the quality as described in your Section 510(k) premarket will anow you to begin marketing your ence of your device to a legally marketed nonification. The I Driving of Sication for your device and thus, permits your device to proceed to the market.
5
Page 2 --
If you desire specific information about the application of labeling requirements to your device, of In If you destic specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and and any and any a of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vitto Diagliosite Device Devaluation and bareer to premarket notification" (21CFR Part $07.97). regulation entitled, "Misoranang of responsibilities under the Act from the Act from the You may obtain other general information on your reposumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
:
:
.
:
| 510(k) Number (if known): | K050448 |
|---|---|
| Device Name: | CHROMOPEP AT |
Indications For Use:
CHROMOPEP AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off Divise of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
Continues and Safety Office of in 11:24
Evaluation and Safety
510(k) K050448
Page 1 of _1
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Indications for Use
| 510(k) Number (if known): | K050448 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the Chritomor E. TO lo internation of Protein C activity in citrated human plasma.
Prescription Use $\surd$
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dauphine Bautte
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050448
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