(71 days)
No
The summary describes a photometric assay for determining factor VIII activity. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on method comparison and precision, which are standard for in vitro diagnostic assays.
No
The device is an in vitro diagnostic (IVD) device used for photometric determination of factor VIII activity in plasma. It is used for diagnostic purposes (identifying deficiency, monitoring), not for directly treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use," and it is intended for determining factor VIII activity to identify deficiency or monitor patients, which are diagnostic purposes.
No
The device description and performance studies clearly indicate this is an in vitro diagnostic (IVD) reagent kit used for photometric determination, which involves chemical reactions and physical measurements, not solely software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
Furthermore, the intended use describes the device's purpose as determining factor VIII activity in citrated plasma for diagnostic purposes (identifying deficiency, monitoring therapy). This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVIII concentrates.
Product codes
GGP
Device Description
Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVII concentrates.
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
Method Comparison: In method comparison studies evaluating citrated plasma samples, the slopes and correlation coefficients (r) obtained for Coatest SP FVIII versus the following reference methods showed statistically similar performances:
Manual Method vs. Coatest FVIII (K833892): n=181, Slope=1.0851, r=0.9873
ACL 9000 vs. Coamatic FVIII (K981038): n=90, Slope=0.9987, r=0.9919
Precision: Within run and total precision was assessed over multiple runs (n=80) using both normal and abnormal samples.
Manual Method - High Abnormal Control: Mean % Factor VIII = 14.4, Within run CV% = 4.3, Total CV% = 5.6
Manual Method - Normal Control: Mean % Factor VIII = 83, Within run CV% = 3.4, Total CV% = 5.3
ACL 9000 - High Abnormal Control: Mean % Factor VIII = 17.3, Within run CV% = 5.7, Total CV% = 6.3
ACL 9000 - Normal Control: Mean % Factor VIII = 102, Within run CV% = 4.7, Total CV% = 7.1
Key Metrics
Method Comparison: Slope, r (correlation coefficient).
Precision: Within run CV%, Total CV%.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 2004
Section 3 Coatest SP FVIII - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
September 21, 2004
Name of the Device:
Coatest SP FVIII
Classification Name:
864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficiency
Identification of predicate device:
K833892 Coatest Factor VIII
Description of the device:
Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVII concentrates.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Coatest SP FVIII is substantially equivalent in performance and safety and effectiveness to the predicate device: Coatest Factor VIII.
1
Section 3 (Cont.) Coatest SP FVIII - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating citrated plasma samples, the slopes and correlation coefficients (r) obtained for Coatest SP FVIII versus the following reference methods showed statistically similar performances:
| Reference Method | n | Slope | r | |
|---|---|---|---|---|
| Manual Method | Coatest FVIII (K833892) | 181 | 1.0851 | 0.9873 |
| ACL 9000 | Coamatic FVIII (K981038) | 90 | 0.9987 | 0.9919 |
Precision
Within run and total precision was assessed over multiple runs (n=80) using both normal and abnormal samples:
| | Control | Mean
% Factor VIII | Within run
CV% | Total
CV% |
|------------------|-----------------------|-----------------------|-------------------|--------------|
| Manual
Method | High Abnormal Control | 14.4 | 4.3 | 5.6 |
| | Normal Control | 83 | 3.4 | 5.3 |
| ACL 9000 | High Abnormal Control | 17.3 | 5.7 | 6.3 |
| | Normal Control | 102 | 4.7 | 7.1 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
DEC - 2 2004
Re: K042576
Trade/Device Name: Coatest SP FVIII Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: November 9, 2004 Received: November 10, 2004
Dear Ms. Marble:
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, rryou don't specific most on advertising of your device, please contact the Office of In or questions on the process 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 r ou may outmer generers, 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Coatest SP FVIII
Indications for Use:
Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVIII concentrates.
For in vitro diagnostic use.
V Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KC42576
Coatest SP FVIII 510(k)