(113 days)
Not Found
Not Found
No
The summary describes a standard coagulation test and instrument without any mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) test used for monitoring heparin anticoagulation, not for treating a condition.
Yes.
The document states "The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use".
No
The description explicitly states the test is performed "on the HEMOCHRON® Jr. microcoagulation instrument," indicating a hardware component is required.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use..."
This statement directly identifies the device as being for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.
Product codes
GFO, JPA
Device Description
Not Found
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
point-of-care testing
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.
Not Found
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
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 1997
-.
Robert H. Matland Chief Compliance Officer International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820
K972831 Re : Hemochron Citrate APTT Requlatory Class: II Product Code: GFO, JPA Dated: October 3, 1997 Received: October 7, 1997
Dear Mr. Matland:
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 general controls provisions The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth 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 regulatory 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 requlations.
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Page 2
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 qeneral 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 Ditman
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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Page _ of _
510(k) Number (if known): K97283) Device Name: Hemochron Citrate APTT
Indications For Use:
.. .
The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended ---for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O
Division of Cli
ces
510(k) Number K979831
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)