(63 days)
No
The description focuses on a traditional in vitro diagnostic assay based on a calibration curve and does not mention any AI/ML components.
No
The device is an in vitro diagnostic intended for the quantitative determination of Factor VII activity in citrated plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is an "in vitro diagnostic quantitative determination" for Factor VII activity, which is a diagnostic purpose. It helps determine abnormalities of extrinsic pathway factors by measuring clotting time.
No
The device is a biological 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).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is "intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma".
- Device Description: The description reiterates its purpose for "in vitro diagnostic quantitative determination of Factor VII activity".
- Mechanism: It describes a laboratory test performed on a patient sample (citrated plasma) to measure a specific analyte (Factor VII activity) to aid in diagnosis. This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
GJT
Device Description
HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.
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 60 citrated plasma samples (30 normal/ 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VII Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor VII Deficient Plasma vs. Predicate Hemoliance Factor VII Deficient Plasma on ELECTRA
IL System: E1400C, Slope: 0.9683, r: 0.9967
HemosIL Factor VII Deficient Plasma vs. Predicate IL Test Factor VII Deficient Plasma on ACL Family
IL System: ACL 300, Slope: 1.0045, r: 0.9994
IL System: ACL 6000, Slope: 0.9646, r: 0.9989
IL System: ACL 9000, Slope: 0.9778, r: 0.9996
IL System: ACL Futura, Slope: 0.9678, r: 0.9943
Within Run Precision: Within run and total precision assessed over multiple runs (n=80) using two levels of control gave the following results:
Instrument: ACL 300, Control: Normal Control, Mean % Factor VII: 99.6, Within run CV%: 1.0, Total CV%: 2.9
Instrument: ACL 300, Control: Low Abnormal Control, Mean % Factor VII: 49.1, Within run CV%: 1.2, Total CV%: 2.7
Instrument: ACL 6000, Control: Normal Control, Mean % Factor VII: 100.5, Within run CV%: 1.4, Total CV%: 1.9
Instrument: ACL 6000, Control: Low Abnormal Control, Mean % Factor VII: 49.9, Within run CV%: 1.5, Total CV%: 2.5
Instrument: ACL 9000, Control: Normal Control, Mean % Factor VII: 99.4, Within run CV%: 0.8, Total CV%: 2.7
Instrument: ACL 9000, Control: Low Abnormal Control, Mean % Factor VII: 47.6, Within run CV%: 1.4, Total CV%: 3.6
Instrument: ACL Advance, Control: Normal Control, Mean % Factor VII: 99.9, Within run CV%: 4.7, Total CV%: 5.7
Instrument: ACL Advance, Control: Low Abnormal Control, Mean % Factor VII: 50.9, Within run CV%: 4.6, Total CV%: 5.9
Instrument: ELECTRA 1400C, Control: Normal Control, Mean % Factor VII: 79.4, Within run CV%: 2.2, Total CV%: 2.7
Instrument: ELECTRA 1400C, Control: Low Abnormal Control, Mean % Factor VII: 37.8, Within run CV%: 2.4, Total CV%: 3.4
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 VII 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 781-861-4207 Fax:
FEB 1 2 2003
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
December 10, 2002
Name of the Device:
HemosIL Factor VII Deficient Plasma
Classification Name(s):
| 864.7290 | Factor Deficiency Tests | Class II |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient |
Identification of Predicate Device(s):
Hemoliance Factor VII Deficient Plasma on ELECTRA Series Analyzers K893535 IL Test Factor VII 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 VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor VII Deficient Plasma is substantially equivalent to Hemoliance Factor VII Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor VII Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3 HemosIL Factor VII Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating 60 citrated plasma samples (30 normal/ 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VII Deficient Plasma versus the predicate devices are shown below:
NOTE: HemosIL RecombiPlasTin (K012768) was used as the PT reagent in all testing.
HemosIL Factor VII Deficient Plasma vs. Predicate Hemoliance Factor VII Deficient Plasma on ELECTRA
| IL System | Slope | r |
|---|---|---|
| E1400C | 0.9683 | 0.9967 |
HemosIL Factor VII Deficient Plasma vs. Predicate IL Test Factor VII Deficient Plasma on ACL Family
| IL System | Slope | r |
|---|---|---|
| ACL 300 | 1.0045 | 0.9994 |
| ACL 6000 | 0.9646 | 0.9989 |
| ACL 9000 | 0.9778 | 0.9996 |
| ACL Futura | 0.9678 | 0.9943 |
Within Run Precision
Within run and total precision assessed over multiple runs (n=80) using two levels of control gave the following results:
| Instrument | Control | Mean
% Factor VII | Within run
CV% | Total
CV% |
|------------------|----------------------|----------------------|-------------------|--------------|
| ACL 300 | Normal Control | 99.6 | 1.0 | 2.9 |
| | Low Abnormal Control | 49.1 | 1.2 | 2.7 |
| ACL 6000 | Normal Control | 100.5 | 1.4 | 1.9 |
| | Low Abnormal Control | 49.9 | 1.5 | 2.5 |
| ACL 9000 | Normal Control | 99.4 | 0.8 | 2.7 |
| | Low Abnormal Control | 47.6 | 1.4 | 3.6 |
| ACL Advance | Normal Control | 99.9 | 4.7 | 5.7 |
| | Low Abnormal Control | 50.9 | 4.6 | 5.9 |
| ELECTRA
1400C | Normal Control | 79.4 | 2.2 | 2.7 |
| | Low Abnormal Control | 37.8 | 2.4 | 3.4 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines suggesting movement or connection. The overall design is simple and conveys a sense of unity and service.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
FEB 1 2 2003
Re: K024082 Trade/Device Name: HemosIL Factor VII Deficient Plasma Regulation Number: 21 CFR § 864,7290 Regulation Name: Plasma, Coagulation Factor Deficient Regulatory Class: II Product Code: GJT Dated: December 10, 2002 Received: December 11, 2002
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
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HemosIL Factor VII Deficient Plasma
Indications for Use:
Hemos L Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) 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)
Josephine Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices K024082
510(k) Number
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
HemosIL Factor VII Deficient Plasma 510(k)