(28 days)
Not Found
No
The summary describes a standard in vitro diagnostic test for Factor VIII activity, with no mention of AI or ML technologies in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic test for measuring Factor VIII activity, which is used for identification or monitoring, not for treating a condition.
Yes
The device is described as an "in vitro diagnostic test" for the quantitative determination of Factor VIII activity, which is used as an aid in identifying Factor VIII deficiency or monitoring patients on replacement therapy, clearly indicating a diagnostic purpose.
No
The device is an in vitro diagnostic test kit, which includes reagents and likely other physical components for performing laboratory tests. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma..."
The "Device Description" section also states: "Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma..."
These statements clearly identify the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in the indentification of factor VIII deficiency or to monitor patients on replacement therapy as well as for potency estimation of FVIII concentrates.
Product codes
81GGP
Device Description
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods.
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
In a method comparison study evaluating 69 plasma samples, the correlation (r) of the new Coamatic® Factor VIII on a Cobas Mira S as compared to the predicate Coatest® Factor VIII using a manual test tube method was 0.99.
Within run precision assessed over multiple runs gave a CV of 1.87% (at a Factor VIII concentration of 1.0 IU/mL), 2.57% (at a Factor VIII concentration of 0.21 IU/mL) and 2.76% (at a Factor VIII concentration of 0.025 IU/mL).
Key Metrics
Correlation (r): 0.99
CV: 1.87% (at 1.0 IU/mL), 2.57% (at 0.21 IU/mL), 2.76% (at 0.025 IU/mL)
Predicate Device(s)
Reference Device(s)
Not Found
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
APR 1 6 1998
Section 3 Coamatic® Factor VIII - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Contact Persons:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
March 18, 1998
Name of the device:
Coamatic® Factor VIII
Classification name(s):
864.7290 Factor Deficiency Test Class II Test, Qualitative and Quantitative Factor Deficiency 81GGP
Identification of predicate device(s):
Coatest® Factor VIII K833892
Description of the device/intended use(s):
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in the indentification of factor VIII deficiency or to monitor patients on replacement therapy as well as for potency estimation of FVIII concentrates.
Statement of How the Technological Characteristics of the Device Compare to the Predicate Device:
Coamatic® Factor VIII uses the same general test principle as the predicate Coatest® Factor VIII and is substantially equivalent in performance, intended use, and safety and effectiveness.
Summary of Performance Data:
In a method comparison study evaluating 69 plasma samples, the correlation (r) of the new Coamatic® Factor VIII on a Cobas Mira S as compared to the predicate Coatest® Factor VIII using a manual test tube method was 0.99.
Within run precision assessed over multiple runs gave a CV of 1.87% (at a Factor VIII concentration of 1.0 IU/mL), 2.57% (at a Factor VIII concentration of 0.21 IU/mL) and 2.76% (at a Factor VIII concentration of 0.025 IU/mL).
Coamatic® Factor VIII 510(k)
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR | 6 1398
Carol Marble . Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
K981038 Re : Coamatic® Factor VIII Requlatory Class: II Product Code: GGP Dated: March 18, 1998 Received: March 19, 1998
Dear Ms. Marble:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, -as setforth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): __
Device Name: Coamatic® Factor VIII
Indications for Use:
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in identifying factor VIII deficiency or monitoring patients on replacement therapy as well as for potency estimation of FVIII concentrates.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
981038
Prescription Use (Per 21 CFR 801.019) OR
Over-The-Counter Use _
Section 2
Coamatic® Factor VIII 510(k)