(74 days)
K933252/S
Not Found
No
The summary describes a reagent for in vitro diagnostic testing and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is an in vitro diagnostic intended for determining Prothrombin Time and Fibrinogen in human plasma. It evaluates the extrinsic coagulation pathway and monitors Oral Anticoagulant Therapy, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device permits "in vitro diagnostic determination." This clearly indicates its role in diagnosing medical conditions based on laboratory tests.
No
The device description explicitly states it is a "recombinant rabbit tissue factor based thromboplastin," which is a reagent, not software. The performance studies also involve testing on physical laboratory systems (ACL 3000 and ACL Futura).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma..."
The "Device Description" section also states: "IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma..."
These statements clearly indicate that the device is intended for diagnostic testing performed outside of the living body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.
Product codes
GJS, GIS
Device Description
IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin.
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 method comparison studies evaluating normal and abnormal plasma samples (n=79) on an ACL 3000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ PT-Fibrinogen Recombinant versus the predicate device are shown below: System ACL 3000 PT (seconds) Slope 1.04 r 0.918 Fibrinogen (mg/dL) Slope 0.93 r 0.977 System ACL Futura PT (seconds) Slope 1.09 r 0.949 Fibrinogen (mg/dL) Slope 1.05 r 0.982. Within run precision assessed over multiple runs using both normal and abnormal samples gave the following results: ACL 3000 PT (seconds) Normal Mean 10.97 % CV 0.53 Abnormal Mean 24.52 % CV 1.20 Fibrinogen (mg/dL) Normal Mean 216.04 % CV 4.25 Abnormal Mean 116.30 % CV 4.36 ACL Futura PT (seconds) Normal Mean 11.98 % CV 1.37 Abnormal Mean 27.69 % CV 1.99 Fibrinogen (mg/dL) Normal Mean 261.55 % CV 5.03 Abnormal Mean 106.11 % CV 2.90.
Key Metrics
Method comparison studies: ACL 3000 PT (seconds) Slope 1.04, r 0.918; Fibrinogen (mg/dL) Slope 0.93, r 0.977. ACL Futura PT (seconds) Slope 1.09, r 0.949; Fibrinogen (mg/dL) Slope 1.05, r 0.982. Precision: ACL 3000 PT (seconds) Normal Mean 10.97, % CV 0.53; Abnormal Mean 24.52, % CV 1.20. Fibrinogen (mg/dL) Normal Mean 216.04, % CV 4.25; Abnormal Mean 116.30, % CV 4.36. ACL Futura PT (seconds) Normal Mean 11.98, % CV 1.37; Abnormal Mean 27.69, % CV 1.99. Fibrinogen (mg/dL) Normal Mean 261.55, % CV 5.03; Abnormal Mean 106.11, % CV 2.90.
Predicate Device(s)
IL Test™ PT-Fibrinogen HS Plus K933252/S
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL - 7 1998
Section 3
IL Test™ PT-Fibrinogen Recombinant - 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:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
April 23, 1998
Name of the Device:
IL Test™ PT-Fibrinogen Recombinant
Classification Name(s):
| 864.7340 | Fibrinogen determination system | Class II |
|---|---|---|
| 864.7750 | Prothrombin time test | Class II |
| 81GIS | Test, fibrinogen | |
| 81GIS | Test, time, prothrombin |
Identification of Predicate Device(s):
IL Test™ PT-Fibrinogen HS Plus K933252/S
Description of the Device/Intended use(s):
IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
IL Test™ PT-Fibrinogen Recombinant has the same test principle as the predicate IL Test™ PT-Fibrinogen HS Plus and is substantially equivalent in performance, intended use and safety and effectiveness.
IL Test™ PT-Fibrinogen Recombinant 510(k)
169814799
1
Section 3 IL Test™ PT-Fibrinogen Recombinant - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
In method comparison studies evaluating normal and abnormal plasma samples (n=79) on an ACL 3000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ PT-Fibrinogen Recombinant versus the predicate device are shown below:
| System | PT (seconds) | Fibrinogen (mg/dL) | ||
|---|---|---|---|---|
| Slope | r | Slope | r | |
| ACL 3000 | 1.04 | 0.918 | 0.93 | 0.977 |
| ACL Futura | 1.09 | 0.949 | 1.05 | 0.982 |
Within run precision assessed over multiple runs using both normal and abnormal samples gave the following results:
| PT (seconds) | Fibrinogen (mg/dL) | ||||||
|---|---|---|---|---|---|---|---|
| ACL 3000 | Normal | Abnormal | Normal | Abnormal | |||
| Mean | 10.97 | 24.52 | 216.04 | 116.30 | |||
| % CV | 0.53 | 1.20 | 4.25 | 4.36 | |||
| ACL Futura | PT (seconds) | Normal | Abnormal | Fibrinogen (mg/dL) | Normal | Abnormal | |
| Normal | Abnormal | Normal | Abnormal | ||||
| Mean | 11.98 | 27.69 | 261.55 | 106.11 | |||
| % CV | 1.37 | 1.99 | 5.03 | 2.90 |
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 JUL
Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re: K981479 IL Test PT-Fibrinogen Recombinant Regulatory Class: II Product Code: GJS, GIS Dated: April 23, 1998 Received: April 24, 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 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 aqainst 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. ದಿ 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
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 "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Steven Autman
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
4
Indications for Use Statement
81479 510(k) Number (if known):
Device Name: IL Test™ PT-Fibrinogen Recombinant
Indications for Use:
IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity 事 recombinant rabbit tissue factor based thromboplastin.
This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.
(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 _4981479
Prescription Use
(Per 21 CFR 801.019)
:
OR Over-The-Counter Use _
IL Test™ PT-Fibrinogen Recombinant 510(k)