(35 days)
No
The summary describes a reagent and its performance on existing coagulation analyzers, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an "in vitro diagnostic determination," meaning it determines parameters in samples outside the living body, rather than directly treating a condition within the body.
Yes
The text explicitly states "in vitro diagnostic determination" concerning the measurement of Prothrombin Time (PT) and Fibrinogen, indicating its use for diagnostic purposes.
No
The device is a reagent (HemosIL RecombiPlasTin) used in conjunction with coagulation systems (IL Coagulation and ELECTRA Systems, ACL Futura, ACL Advance, ACL TOP). Reagents are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the product is for "quantitative in vitro diagnostic determination in human citrated plasma." This is a clear indication of an in vitro diagnostic use.
- Device Description: The description reiterates the "in vitro diagnostic determination" of Prothrombin Time and Fibrinogen in human plasma.
- Purpose: The product is used for "evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT)," which are diagnostic purposes performed on a sample taken from the body.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- Fibrinogen on IL Coagulation Systems only .
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Product codes
GJS, GIS
Device Description
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- . Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.
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
Within run and total precision assessed over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen gave the following results:
| Prothrombin Time (PT) | Mean (Seconds) | CV% (Within run) | CV% (Total) |
|---|---|---|---|
| Normal Control | 11.6 | 0.9 | 1.3 |
| Low Abnormal Control | 30.3 | 1.4 | 2.3 |
| High Abnormal Control | 51.1 | 1.4 | 3.9 |
In a method comparison study evaluating 98 citrated plasma samples, the slopes and correlation coefficients (r) are shown below for the legally marketed HemosIL RecombiPlasTin on an ACL Advance with optimized PT and fibrinogen parameters versus Hemos L RecombiPlasTin for PT and HemosIL Fibrinogen-C (K931721) for fibrinogen on the ACL TOP:
| Slope | r | |
|---|---|---|
| PT (seconds) | 1.039 | 0.9985 |
| Fibrinogen (mg/dL) | 0.938 | 0.9811 |
Key Metrics
Refer to Summary of Performance Studies.
Predicate Device(s)
Reference Device(s)
K951891, K002400, K033414, K931721
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
DEC 22 2004
Section 3 HemosIL RecombiPlasTin 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
November 16, 2004
Device Name:
HemosIL RecombiPlasTin
Classification Name:
| 864.7750 | Prothrombin Time Test | Class II |
|---|---|---|
| 81GJS | Test, Time, Prothrombin | |
| 864.7340 | Fibrinogen Determination System | Class II |
| 81GIS | Test, Fibrinogen |
Legally Marketed Device:
K012768 HemosIL RecombiPlasTin
Device Description:
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- . Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of HemosIL RecombiPlasTin with optimized PT and fibrinogen parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially Pauinalers to the performance of the current legally marketed device on the ACL TOP (K033414).
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Section 3 HemosIL RecombiPlasTin 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Within Run Precision
Within run and total precision assessed over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen gave the following results:
| Prothrombin Time (PT) | Mean (Seconds) | CV% (Within run) | CV% (Total) |
|---|---|---|---|
| Normal Control | 11.6 | 0.9 | 1.3 |
| Low Abnormal Control | 30.3 | 1.4 | 2.3 |
| High Abnormal Control | 51.1 | 1.4 | 3.9 |
Method Comparison
In a method comparison study evaluating 98 citrated plasma samples, the slopes and correlation coefficients (r) are shown below for the legally marketed HemosIL RecombiPlasTin on an ACL Advance with optimized PT and fibrinogen parameters versus Hemos L RecombiPlasTin for PT and HemosIL Fibrinogen-C (K931721) for fibrinogen on the ACL TOP:
| Slope | r | |
|---|---|---|
| PT (seconds) | 1.039 | 0.9985 |
| Fibrinogen (mg/dL) | 0.938 | 0.9811 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the bird symbol in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 2004
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
K043184 Re:
Trade/Device Name: HemosIL RecombiPlasTin- Optimized Parameter Settings on the ACL Futura/ ACL Advance
Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time set Regulatory Class: Class II Product Code: GJS Dated: December 6, 2004 Received: December 8, 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 (OS) 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.
3
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 (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 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/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. 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: HemosIL RecombiPlasTin - Optimized Parameter Settings on the ACL Futura/ACL Advance
Indications for Use:
HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
- Fibrinogen on IL Coagulation Systems only .
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(OIVD)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices
| Divis | |
|---|---|
| Offic | |
| Evalua. | |
| 510(k) | K043184 |