(32 days)
Not Found
No
The summary describes a reagent for in vitro diagnostic testing and does not mention any AI or ML components.
No
This device is an in vitro diagnostic reagent used for laboratory testing of blood samples to measure Prothrombin Time and Fibrinogen, not for direct treatment or therapy of a patient.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "for the quantitative in vitro diagnostic determination" of Prothrombin Time and Fibrinogen, which are used for "evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT)." This clearly indicates its role in diagnosing and monitoring medical conditions.
No
The device is a reagent, which is a chemical substance used in a laboratory test. This is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "for the quantitative in vitro diagnostic determination in human citrated plasma". This directly identifies the device's purpose as being used outside of the body for diagnostic purposes.
- Device Description: The description reiterates the intended use, again stating "for the in vitro diagnostic quantitative determination in human citrated plasma".
- Purpose: The intended use and description clearly indicate the device is used to analyze a human sample (citrated plasma) to provide information about a physiological state (coagulation pathway, monitoring OAT). This is the core function of an IVD.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GJS, GGP, GIS
Device Description
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative 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).
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)
Method Comparison
In method comparison studies evaluating 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples) on an ACL 3000, ACL Futura and ELECTRA 1400C, the slopes and correlation coefficients (r) for HemosIL RecombiPlasTin versus the predicate devices are shown below:
Prothrombin Time (seconds) on IL Coagulation and ELECTRA Systems:
New Device vs. Predicate Device for PT: Hemoliance® RecombiPlasTin
IL System ACL 9000 Slope 0.90 r 0.993
IL System ACL Futura Slope 0.99 r 0.995
IL System E1400C Slope 0.95 r 0.996
Fibrinogen (mg/dL) on IL Coagulation Systems Only:
New Device vs. Predicate Device for Fib: IL Test™ PT-Fibrinogen*
IL System ACL 9000 Slope 1.00 r 0.933
IL System ACL Futura Slope 1.10 r 0.957
*NOTE: Values outside the linearity claim of 700 mg/dL were removed from calculations for a respective n=164 on the ACL 9000 and n=170 on the ACL Futura.
Within Run Precision
Within run precision assessed over multiple runs using three levels for Prothrombin Time and two levels for Fibrinogen of control plasmas gave the following results:
PT (seconds)
ACL 9000 Level 1 Mean 11.8 % CV 0.8
ACL 9000 Level II Mean 28.8 % CV 2.5
ACL 9000 Level III Mean 57.1 % CV 1.7
ACL Futura Level 1 Mean 11.0 % CV 1.1
ACL Futura Level II Mean 30.4 % CV 1.2
ACL Futura Level III Mean 61.6 % CV 1.1
E1400C Level 1 Mean 12.3 % CV 0.9
E1400C Level II Mean 29.0 % CV 1.9
E1400C Level III Mean 57.8 % CV 2.1
Fibrinogen (mg/dL)
ACL 9000 Level 1 Mean 303 % CV 4.3
ACL 9000 Low Fibrinogen Mean 127 % CV 3.6
ACL Futura Level 1 Mean 261 % CV 4.5
ACL Futura Low Fibrinogen Mean 119 % CV 9.8
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).
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Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4464
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
August 16, 2001
Name of the Device:
HemosIL RecombiPlasTin
Classification Name(s):
| 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):
K925604 Hemoliance® RecombiPlasTin (PT Claims for IL Coagulation and ELECTRA Systems) K862301 IL Test™ PT-Fibrinogen (Fibrinogen Claims for IL Coagulation Systems Only)
Description of the Device/Intended Use(s):
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative 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).
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL RecombiPlasTin is substantially equivalent to Hemoliance® RecombiPlasTin (for Prothrombin Time on IL Coagulation and ELECTRA Systems) and IL Test™ PT-Fibrinogen (for Fibrinogen on IL Coagulation Systems only) in performance, intended use and safety and effectiveness.
1
Section 3 HemosIL RecombiPlasTin - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples) on an ACL 3000, ACL Futura and ELECTRA 1400C, the slopes and correlation coefficients (r) for HemosIL RecombiPlasTin versus the predicate devices are shown below:
Prothrombin Time (seconds) on IL Coagulation and ELECTRA Systems:
New Device vs. Predicate Device for PT: Hemoliance® RecombiPlasTin
| IL System | Slope | r |
|---|---|---|
| ACL 9000 | 0.90 | 0.993 |
| ACL Futura | 0.99 | 0.995 |
| E1400C | 0.95 | 0.996 |
Fibrinogen (mg/dL) on IL Coagulation Systems Only:
New Device vs. Predicate Device for Fib: IL Test™ PT-Fibrinogen*
| IL System | Slope | r |
|---|---|---|
| ACL 9000 | 1.00 | 0.933 |
| ACL Futura | 1.10 | 0.957 |
*NOTE: Values outside the linearity claim of 700 mg/dL were removed from calculations for a respective n=164 on the ACL 9000 and n=170 on the ACL Futura.
Within Run Precision
Within run precision assessed over multiple runs using three levels for Prothrombin Time and two levels for Fibrinogen of control plasmas gave the following results:
| PT (seconds) | Fibrinogen (mg/dL) | ||||
|---|---|---|---|---|---|
| ACL 9000 | Level 1 | Level II | Level III | Level 1 | Low Fibrinogen |
| Mean | 11.8 | 28.8 | 57.1 | 303 | 127 |
| % CV | 0.8 | 2.5 | 1.7 | 4.3 | 3.6 |
| ACL Futura | Level 1 | Level II | Level III | Level 1 | Low Fibrinogen |
| Mean | 11.0 | 30.4 | 61.6 | 261 | 119 |
| % CV | 1.1 | 1.2 | 1.1 | 4.5 | 9.8 |
| E1400C | Level 1 | Level II | Level III | ||
| Mean | 12.3 | 29.0 | 57.8 | ||
| % CV | 0.9 | 1.9 | 2.1 |
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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 consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, curved design. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
SEP 1 8 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
K012768 Re:
Trade Name: HemosIL RecombiPlasTin Regulation Number: 21 CFR § 864.7750 and 21 CFR § 864.7340 Regulatory Class: II Product Code: GJS, GGP, GIS Dated: August 16, 2001 Received: August 17, 2001
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 action. In addition, FDA may publish further announcements 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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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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
510(k) Number (if known): K012768
Device Name: HemosIL RecombiPlasTin
Indications for Use:
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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
aboratory Devices
510(k) Number K012768
Prescription Use (Per 21 CFR 801.019) OR
Over-The-Counter Use
Section 2
HemosIL RecombiPlasTin 510(k)