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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for two devices, Chromopep PC and Chromopep AT, which are chromogenic assays for quantitative determination of Protein C and Antithrombin activity, respectively. These are IVD devices and the provided summary focuses on demonstrating their substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted from this document, as they typically apply to studies evaluating new medical devices and their performance against clinical endpoints or ground truth.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission for IVD assays, the "acceptance criteria" are implied by demonstrating that the new devices perform comparably to their legally marketed predicate devices. The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) or directly report performance metrics in the way a clinical study for a treatment device might. Instead, the performance is demonstrated through comparison to the predicate devices, implying that if they are "substantially equivalent" in design and intended use, their performance will also be equivalent and acceptable.

Acceptance Criteria (Implied)	Reported Device Performance (Implied by Substantial Equivalence Claim)
Substantially equivalent to predicate device: Chromocheck Protein C concerning Device Name, Intended Use, Analytes, Component Reagent Matrices, Format, and Packaging.	Chromopep PC is considered substantially equivalent to Chromocheck Protein C.
Substantially equivalent to predicate device: Chromocheck Antithrombin AT concerning Device Name, Intended Use, Analytes, Component Reagent Matrices, Format, and Packaging.	Chromopep AT is considered substantially equivalent to Chromocheck Antithrombin.

2. Sample size used for the test set and the data provenance:

The document does not provide details of specific test sets, sample sizes, or data provenance. The submission focuses on the design and intended use equivalence to predicate devices. It is typical for IVD submissions regarding substantial equivalence to include performance data (e.g., accuracy, precision, linearity, interference studies), but this specific summary does not present those details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. For IVD assays, "ground truth" often refers to a reference method or known concentration/activity of the analyte. The summary does not describe any expert adjudication for establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Expert adjudication methods are typically used in imaging or clinical diagnostic studies where subjective interpretation is involved. This document pertains to quantitative laboratory assays.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. MRMC studies and AI assistance are not relevant to this type of IVD chromogenic assay.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. These are laboratory reagents for quantitative assays, not AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the "ground truth" used for performance assessment. For quantitative IVD assays, ground truth typically refers to:

Reference methods (e.g., gold standard laboratory tests).
Certified reference materials with known analyte concentrations.
Spiked samples with known amounts of the analyte.

The summary emphasizes the comparison to predicate devices, implying that their established performance serves as a benchmark rather than a separate ground truth study outlined here.

8. The sample size for the training set:

Not applicable. These are chemical reagents for performing assays, not machine learning or AI models that require training sets.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for these types of IVD devices.

Summary

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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.

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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
ComponentReagentMatrices	Reagent 1 : Protein C activator in a distilledwater matrix (0.65 IU)Reagent 2 : Chromogenic substrate in adistilled water matrix	Reagent 1 : Protein C activator in adistilled water matrix (0.65 IU)Reagent 2 : Chromogenic substrate in adistilled water matrix
Format	Lyophilized	Lyophilized
Packaging	Chromocheck Protein C 254 x Protein C Activator (0.65IU)4 x Substrate (4mg)(Reconstituted volume - 2.5ml)Chromocheck Protein C 504 x Protein C Activator (1.30IU)4 x Substrate (8mg)(Reconstituted volume - 5.0ml)	Chromopep PC 2.54 x Protein C Activator (0.65IU)4 x Substrate (4mg)(Reconstituted volume - 2.5ml)Chromopep PC 54 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
ComponentReagentMatrices	Reagent 1 : Factor Xa - Bovine Factor Xain a Tris Heparin Buffer matrixReagent 2 : Chromogenic substrate in adistilled water matrixReagent 3 : Tris Heparin Buffer	Reagent 1 : Factor Xa - Bovine Factor Xain a Tris Heparin Buffer matrixReagent 2 : Chromogenic substrate in adistilled water matrixReagent 3 : Tris Heparin Buffer
Format	Lyophilized	Lyophilized
Packaging	Chromocheck Antithrombin 254 x Factor Xa (5µg)4 x Substrate (3.75mg)4 x 5mL Tris Heparin BufferChromocheck Antithrombin 504 x Factor Xa (10µg)4 x Substrate (7.5mg)4 x 10mL Tris Heparin Buffer	Chromopep AT 2.54 x Factor Xa (5µg)4 x Substrate (3.75mg)4 x 5mL Tris Heparin BufferChromopep AT 54 x Factor Xa (10µg)4 x Substrate (7.5mg)4 x 10mL Tris Heparin Buffer

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Conclusions :

Chromopep PC can be considered as substantially equivalent to Chromocheck Protein C.

Chromopep AT can be considered as substantially equivalent to Chromocheck Antithrombin.

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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.

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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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Regulation Number and Section

§ 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).