(27 days)
Not Found
No
The document describes a reagent for coagulation testing and does not mention any AI or ML components.
No
This device is for in vitro diagnostic use, meaning it's used to analyze samples outside the body to help diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use."
No
The device description clearly states it is a "calcium thromboplastin," which is a reagent, a physical substance used in a laboratory test. This indicates it is a hardware component (a chemical reagent) and not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
This statement, along with the description of the device being used to perform tests on human citrated plasma to evaluate coagulation and monitor therapy, clearly indicates that it is intended for use in diagnosing or monitoring medical conditions outside of the living body.
N/A
Intended Use / Indications for Use
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
GJS, GIS
Device Description
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.
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)
The expected value ranges for PT and Fibrinogen on the ACL Futura/ACL Advance provided in the product insert for HemosIL PT-Fibrinogen HS PLUS are being updated based on data from a new normal range study.
Summary of New Expected Values Data:
Assay: PT, System: ACL Futura/ACL Advance, N: 119, Range (units): 11.1 - 14.5 (seconds)
Assay: Fibrinogen, System: ACL Futura/ACL Advance, N: 119, Range (units): 262 - 433 (mg/dL)
These results were obtained using a specific lot of reagent. Due to the many variables which may affect clotting times, each laboratory should establish its own reference range.
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.
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
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
0
Section 3 HemosIL PT-Fibrinogen HS PLUS 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
MAY 2 2005
Contact Person:
Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 781-861-4207 Fax No.:
Summary Prepared:
April 4, 2006
Name of the Device:
HemosIL PT-Fibrinogen HS PLUS
Regulatory Information:
| 864.7750 | Prothrombin Time Test | Class II |
|---|---|---|
| 81GJS | Test, Time, Prothrombin | |
| 864.7340 | Fibrinogen Determination System | Class II |
| 81GIS | Test, Fibrinogen |
Identification of Predicate Device(s):
K933252 HemosIL PT-Fibrinogen HS PLUS
Device Description:
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.
Reason for Submission:
The expected value ranges for PT and Fibrinogen on the ACL Futura/ACL Advance provided in the product insert for HemosIL PT-Fibrinogen HS PLUS are being updated based on data from a new normal range study.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of HemosIL PT-Fibrinogen HS PLUS with the new expected value ranges for the ACL Futura and ACL Advance is not materially different from the FDA cleared device.
Summary of New Expected Values Data:
| Assay | System | N | Range (units) |
|---|---|---|---|
| PT | ACL Futura/ACL Advance | 119 | 11.1 - 14.5 (seconds) |
| Fibrinogen | ACL Futura/ACL Advance | 119 | 262 - 433 (mg/dL) |
These results were obtained using a specific lot of reagent. Due to the many variables which may affect clotting times, each laboratory should establish its own reference range.
| Section 3 | Special 510(k): HemosIL PT-Fibrinogen HS PLUS | Page 1 of 1 |
|---|---|---|
| ----------- | ----------------------------------------------- | ------------- |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director MAY Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
2 3005
Re: K060931
Trade/Device Name: HemosIL PT-Fibrinogen HS PLUS Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin time test Regulatory Class: II Product Code: GJS, GIS Dated: April 4, 2006 Received: April 5, 2006
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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K060931
Device Name: HemosIL PT-Fibrinogen HS PLUS
Indications for Use:
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.
For in vitro diagnostic use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Step-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Section 2
Special 510(k): HemosIL PT-Fibrinogen HS PLUS
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