(57 days)
No
The summary describes a diagnostic reagent and its performance characteristics, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of factor V activity in citrated plasma, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of factor V activity."
No
The device description clearly states it is human plasma, which is a biological material, not software. It is an in vitro diagnostic reagent used with specific hardware systems (IL Coagulation and ELECTRA Systems).
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 V activity in citrated plasma".
- Device Description: The description reiterates its intended use for "in vitro diagnostic quantitative determination of factor V activity".
- Mechanism: The description explains how it is used to test patient plasma in vitro (outside the body) to determine factor V activity.
- Performance Studies: The performance studies describe testing of "citrated plasma samples", which are samples taken from patients for laboratory analysis.
All of these points clearly indicate that the device is designed to be used in a laboratory setting to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Product codes (comma separated list FDA assigned to the subject device)
GJT
Device Description
HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V 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 V. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor V 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
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Description of the test set, sample size, data source, and annotation protocol
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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 V Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor V Deficient Plasma vs. Predicate Hemoliance Factor V Deficient Plasma on ELECTRA (IL System E1400C): Slope 1.0161, r 0.9877.
HemosIL Factor V Deficient Plasma vs. Predicate IL Test Factor V Deficient Plasma on ACL Family:
ACL 300: Slope 1.0005, r 0.9932
ACL 6000: Slope 0.9771, r 0.9940
ACL 9000: Slope 0.9746, r 0.9945
ACL Futura: Slope 1.1331, r 0.9814
Within Run Precision:
Within run and total precision assessed over multiple runs (n=80) using two levels of control gave the following results:
ACL 300: Normal Control (Mean % Factor V 110.6, Within run CV% 1.0, Total CV% 3.1), Low Abnormal Control (Mean % Factor V 30.1, Within run CV% 1.8, Total CV% 3.5)
ACL 6000: Normal Control (Mean % Factor V 115.1, Within run CV% 1.5, Total CV% 3.0), Low Abnormal Control (Mean % Factor V 31.5, Within run CV% 1.9, Total CV% 2.8)
ACL 9000: Normal Control (Mean % Factor V 113.7, Within run CV% 1.2, Total CV% 1.7), Low Abnormal Control (Mean % Factor V 29.0, Within run CV% 4.0, Total CV% 5.6)
ACL Advance: Normal Control (Mean % Factor V 132.4, Within run CV% 6.0, Total CV% 7.6), Low Abnormal Control (Mean % Factor V 27.1, Within run CV% 4.1, Total CV% 5.7)
ELECTRA 1400C: Normal Control (Mean % Factor V 101.0, Within run CV% 2.1, Total CV% 3.5), Low Abnormal Control (Mean % Factor V 24.0, Within run CV% 1.5, Total CV% 2.6)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, r, Mean % Factor V, Within run CV%, Total CV%. Specific values are listed in the "Summary of Performance Studies" section.
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.
K893533 Hemoliance Factor V Deficient Plasma on ELECTRA Series Analyzers, K002400 IL Test Factor V Deficient Plasma
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.
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
§ 864.7290 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).
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JAN 1 4 2003
Section 3 HemosIL Factor V 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:
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
November 15, 2002
Name of the Device:
HemosIL Factor V Deficient Plasma
Classification Name(s):
| 864.7290 | Factor Deficiency Tests | Class II |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient | Class II |
Identification of Predicate Device(s):
| K893533 Hemoliance Factor V Deficient Plasma on ELECTRA Series Analyzers |
|---|
| K002400 IL Test Factor V Deficient Plasma* on ACL Family of Analyzers |
| *NOTE: Reagent was 510(k) cleared as part of multiple analyzer systems |
*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 V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V 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 V. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor V in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor V Deficient Plasma is substantially equivalent to Hemoliance Factor V Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor V Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3 HemosIL Factor V 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 V Deficient Plasma versus the predicate devices are shown below:
NOTE: HemosIL RecombiPlasTin (K012768) was used as the PT reagent in all testing.
HemosIL Factor V Deficient Plasma vs. Predicate Hemoliance Factor V Deficient Plasma on ELECTRA
| IL System | Slope | r |
|---|---|---|
| E1400C | 1.0161 | 0.9877 |
HemosIL Factor V Deficient Plasma vs. Predicate IL Test Factor V Deficient Plasma on ACL Family
| IL System | Slope | r |
|---|---|---|
| ACL 300 | 1.0005 | 0.9932 |
| ACL 6000 | 0.9771 | 0.9940 |
| ACL 9000 | 0.9746 | 0.9945 |
| ACL Futura | 1.1331 | 0.9814 |
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 V | Within run
CV% | Total
CV% |
|------------------|----------------------|--------------------|-------------------|--------------|
| ACL 300 | Normal Control | 110.6 | 1.0 | 3.1 |
| | Low Abnormal Control | 30.1 | 1.8 | 3.5 |
| ACL 6000 | Normal Control | 115.1 | 1.5 | 3.0 |
| | Low Abnormal Control | 31.5 | 1.9 | 2.8 |
| ACL 9000 | Normal Control | 113.7 | 1.2 | 1.7 |
| | Low Abnormal Control | 29.0 | 4.0 | 5.6 |
| ACL Advance | Normal Control | 132.4 | 6.0 | 7.6 |
| | Low Abnormal Control | 27.1 | 4.1 | 5.7 |
| ELECTRA
1400C | Normal Control | 101.0 | 2.1 | 3.5 |
| | Low Abnormal Control | 24.0 | 1.5 | 2.6 |
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2003
Ms. Carol Marble IL Regulatory Affairs Director Instrumentation Laboratory 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K023839
Trade/Device Name: HemosIL Factor V Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency tests Regulatory Class: II Product Code: GJT Dated: November 15, 2002 Received: November 18, 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.
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Page 2
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.
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). 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 vours.
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): _ 50 93839
Device Name: HemosIL Factor V Deficient Plasma
Indications for Use:
HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V 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
(División Sigh-Off)
Division of Clinical Laboratory Devices K023839
510(k) Number
Prescription Use
OR Over-The-Counter Use
The-Counter Use
HemosIL Factor V Deficient Plasma 510(k)