(50 days)
Not Found
No
The summary describes a diagnostic reagent and its use in a standard laboratory assay (APTT) on existing coagulation analyzers. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis relies on interpolation from a calibration curve, a traditional method, not an AI/ML algorithm.
No
This device is for in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, not for direct therapeutic use on a patient.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma". The term "in vitro diagnostic" confirms its use as a diagnostic device.
No
The device is a reagent (human plasma) used in an in vitro diagnostic assay, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma..."
This statement clearly indicates that the device is intended for use outside of the body (in vitro) to diagnose a condition (by measuring Factor XI activity).
N/A
Intended Use / Indications for Use
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
81GJT, GJT
Device Description
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in Factor XI. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor XI in the patient plasma, interpolated from a calibration curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison: In method comparison studies evaluating approximately 60 citrated plasma samples (30 normal/30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor XI Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor XI Deficient Plasma vs. Predicate Hemoliance Factor XI Deficient Plasma on ELECTRA (IL System: E1400C, Slope: 1.0063, r: 0.9808).
HemosIL Factor XI Deficient Plasma vs. Predicate IL Test Factor XI Deficient Plasma on ACL Family (IL System: ACL 300, Slope: 0.9605, r: 0.9886; ACL 6000, Slope: 1.0093, r: 0.9669; ACL 9000, Slope: 0.9512, r: 0.9857; ACL Futura, Slope: 0.9924, r: 0.9722).
Within Run Precision: Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of APTT reagent (SynthASil on ELECTRA and APTT-SP on IL Coagulation Systems) and both normal and abnormal samples.
ACL 300: Normal Control (Mean % Factor XI: 81.0, Within run CV%: 4.5, Between Run CV%: 4.4), Low Abnormal Control (Mean % Factor XI: 41.1, Within run CV%: 4.0, Between Run CV%: 5.6).
ACL 6000: Normal Control (Mean % Factor XI: 77.1, Within run CV%: 3.5, Between Run CV%: 4.7), Low Abnormal Control (Mean % Factor XI: 40.9, Within run CV%: 5.4, Between Run CV%: 7.4).
ACL 9000: Normal Control (Mean % Factor XI: 100.5, Within run CV%: 4.5, Between Run CV%: 9.7), Low Abnormal Control (Mean % Factor XI: 49.8, Within run CV%: 4.8, Between Run CV%: 7.5).
ACL Advance: Normal Control (Mean % Factor XI: 97.9, Within run CV%: 4.6, Between Run CV%: 7.5), Low Abnormal Control (Mean % Factor XI: 54.2, Within run CV%: 4.6, Between Run CV%: 5.5).
ELECTRA 1400C: Normal Control (Mean % Factor XI: 136.7, Within run CV%: 2.4, Between Run CV%: 6.8), Low Abnormal Control (Mean % Factor XI: 71.7, Within run CV%: 2.9, Between Run CV%: 6.6).
Key Metrics
Method Comparison: Correlation coefficients (r) ranging from 0.9669 to 0.9886 for method comparison.
Precision: Within run CV% ranging from 2.4% to 5.4%. Between Run CV% ranging from 4.4% to 9.7%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
Section 3 HemosIL Factor XI Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
January 27, 2003
Name of the Device:
HemosIL Factor XI Deficient Plasma
Classification Name(s):
| 864.7290 | Factor Deficiency Tests | Class II |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient |
Identification of Predicate Device(s):
Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers K893536
IL Test Factor XI Deficient Plasma* on ACL Family of Analyzers K002400 *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems, most recently the ACL Advance.
Description of the Device/Intended use(s):
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in Factor XI. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor XI in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor XI Deficient Plasma is substantially equivalent to Hemoliance Factor XI Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor XI Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3 HemosIL Factor XI Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating approximately 60 citrated plasma samples (30 normal/30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor XI Deficient Plasma versus the predicate devices are shown below:
NOTE: IL Test APTT-SP and SynthASil were used as the APTT reagents in all testing.
HemosIL Factor XI Deficient Plasma vs. Predicate Hemoliance Factor XI Deficient Plasma on ELECTRA
| IL System | Slope | r |
|---|---|---|
| E1400C | 1.0063 | 0.9808 |
HemosIL Factor XI Deficient Plasma vs. Predicate IL Test Factor XI Deficient Plasma on ACL Family
| IL System | Slope | r |
|---|---|---|
| ACL 300 | 0.9605 | 0.9886 |
| ACL 6000 | 1.0093 | 0.9669 |
| ACL 9000 | 0.9512 | 0.9857 |
| ACL Futura | 0.9924 | 0.9722 |
Within Run Precision
Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of APTT reagent (SynthASil on ELECTRA and APTT-SP on IL Coagulation Systems) and both normal and abnormal samples.
| Instrument | Control | Mean
% Factor XI | Within run
CV% | Between Run
CV% |
|------------------|----------------------|---------------------|-------------------|--------------------|
| ACL 300 | Normal Control | 81.0 | 4.5 | 4.4 |
| ACL 300 | Low Abnormal Control | 41.1 | 4.0 | 5.6 |
| ACL 6000 | Normal Control | 77.1 | 3.5 | 4.7 |
| ACL 6000 | Low Abnormal Control | 40.9 | 5.4 | 7.4 |
| ACL 9000 | Normal Control | 100.5 | 4.5 | 9.7 |
| ACL 9000 | Low Abnormal Control | 49.8 | 4.8 | 7.5 |
| ACL Advance | Normal Control | 97.9 | 4.6 | 7.5 |
| ACL Advance | Low Abnormal Control | 54.2 | 4.6 | 5.5 |
| ELECTRA
1400C | Normal Control | 136.7 | 2.4 | 6.8 |
| ELECTRA
1400C | Low Abnormal Control | 71.7 | 2.9 | 6.6 |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three intertwined snakes forming a human profile. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2003
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K030287 Trade/Device Name: HemosIL Factor XI Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: January 24, 2003 Received: January 28, 2003
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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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,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K030387
Device Name: HemosIL Factor XI Deficient Plasma
Indications for Use:
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of factor XI and intended for the in vitro diagnostic quantitative determination of factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
(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 | K030287 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- | -- |