(106 days)
Not Found
No
The summary describes a chromogenic assay kit for measuring protein C activity, which is a standard laboratory test and does not mention any AI or ML components.
No
The device is described as an "in vitro chromogenic assay" for the determination of protein C activity in plasma, indicating it is a diagnostic tool, not a therapeutic one.
Yes
This device is intended for the quantitative determination of Protein C activity in human plasma, which is a diagnostic measurement used to assess a patient's health status.
No
The device description clearly states it is a "chromogenic assay consisting of a synthetic substrate and Protein C Activator," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma." The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The assay is performed on "citrated human plasma," which is a biological sample taken from the human body.
- Purpose: The purpose is the "quantitative determination of Protein C activity," which is a measurement of a substance in a biological sample for diagnostic purposes.
These elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
ChromoCheck™ Protein C is intended for use as a 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)
GGP
Device Description
ChromoCheck™ Protein is a chromogenic assay consisting of a synthetic substrate and Protein C Activator.
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)
Correlation: Two lot numbers of ChromoCheck™ Protein C were compared to Coamatic Protein C in a correlation study using a mix of 60 individual normal and pathological patient samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Y-intercept: ChromoCheck Lot 1: 0.632, ChromoCheck Lot 2: -1.308
Slope: ChromoCheck Lot 1: 0.979, ChromoCheck Lot 2: 1.025
R2: ChromoCheck Lot 1: 0.990, ChromoCheck Lot 2: 0.994
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
510(K) Summary ChromoCheck™ Protein C
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: _K023990
| Submitters Name &
Address: | Precision BioLogic Incorporated
900 Windmill Road, Suite 100
Dartmouth, Nova Scotia B3B 1P7
Canada |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff - Director of New Business
Development
Phone: 902-468-6422 ext. 224
Fax: 902-468-6421
Email: sduff@precisionbiologic.com |
| Preparation Date: | November 18, 2002 |
| Device Name &
Classification: | ChromoCheck™ Protein C
Common Name: Protein C chromogenic assay
Classification Name: Test, Quantitative factor
deficiency
Regulatory Class II, 81 GGP |
| Predicate Device: | Chromogenix AB/Instrumentation Laboratory
Taljegardsgatan 3
S-431 53 Molndal
Sweden, SW |
| Device Description: | ChromoCheck™ Protein is a chromogenic assay
consisting of a synthetic substrate and Protein C
Activator. |
| Device Intended Use: | ChromoCheck™ Protein C is intended for use as a
chromogenic assay for the quantitative
determination of Protein C activity in citrated human
plasma. |
1
Comparison to Predicate Device:
| Parameter | ChromoCheck™ Protein C | Coamatic Protein C |
|---|---|---|
| Intended | ||
| Use | Test, Quantitative factor | |
| deficiency | Test, Quantitative factor | |
| deficiency | ||
| Analytes | Protein C activity | Protein C activity |
| Component | ||
| Reagent | ||
| Matrices | Reagent 1: Chromogenic | |
| substrate in distilled water matrix | ||
| Reagent 2: Protein C activator in | ||
| a distilled water matrix | Reagent 1: Chromogenic | |
| substrate in distilled water matrix | ||
| Reagent 2: Protein C activator in a | ||
| distilled water matrix | ||
| Format | Lyophilized | Lyophilized |
| Packaging | 4 x Protein C Activator (0.65 IU) | |
| 4 x Substrate (4 mg) | ||
| (Reconstituted volume - 2.5 mL) |
4 x Protein C Activator (0.65 IU)
4 x Substrate (4 mg)
(Reconstituted volume - 5.0 mL) | 2 x Protein C Activator (1.2 IU)
2 x Substrate S-2366 (6 mg)
(Reconstituted volume - 7.2 mL) |
Comments on Substantial Equivalence:
It is the opinion of Precision BioLogic Inc. that ChromoCheck™ PC is substantially equivalent to Coamatic Protein C (K922201), manufactured by Chromogenix AB, and currently marketed in the United States by Instrumentation Laboratory. This opinion is based on the following similarities:
-
- Both products are intended for use in the quantitative determination of Protein C activity in citrated human plasma
-
- Both devices are based on synthetic chromogenic substrates
-
- Both devices contain a synthetic chromogenic substrate and Protein C Activator and are reconstituted with distilled water
-
- Both devices present results as a % activity of Protein C
-
- Both devices are offered in a lyophilized format
Correlation:
Two lot numbers of ChromoCheck™ Protein C were compared to Coamatic Protein C in a correlation study using a mix of 60 individual normal and pathological patient samples. The following correlation was achieved:
| Correlation
parameter | ChromoCheck
Lot 1 | ChromoCheck
Lot 2 |
|--------------------------|----------------------|----------------------|
| Y-intercept | 0.632 | -1.308 |
| Slope | 0.979 | 1.025 |
| R2 | 0.990 | 0.994 |
Conclusion: ChromoCheck™ Protein C is substantially equivalent to Coamatic Protein C.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The text is all in uppercase letters. The text is centered in the image.
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth. Nova Scotia Canada B3B 1P7
MAR 1 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K023990
Trade/Device Name: ChromoCheck™ Protein C Regulation Number: 21 CFR & 864.7290 Regulation Name: Quantitative Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: February 26, 2003 Received: February 27, 2003
Dear Mr. Duff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number: | KO23990 |
|---|---|
| Device Name: | ChromoCheck™ Protein C |
Indications for Use:
ChromoCheck™ Protein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
Josephine Bautista
(Sign-Off)
of Clinical Laboratory Devices K023990
Number
/ Prescription Use