(48 days)
Not Found
No
The description focuses on a traditional in vitro diagnostic assay based on chemical reactions and interpolation from a calibration curve, with no mention of AI or ML terms or concepts.
No.
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of Factor IX activity, which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states "intended for the in vitro diagnostic quantitative determination of Factor IX activity" and repeatedly uses the phrase "in vitro diagnostic."
No
The device is a reagent (human plasma) used in an in vitro diagnostic test, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma". The phrase "in vitro diagnostic" is a direct indicator.
- Device Description: The description further clarifies that it's used to determine "abnormalities of the intrinsic pathway factors" by performing a modified APTT test on patient plasma. This is a diagnostic procedure performed outside of the body.
- Performance Studies: The performance studies describe method comparisons and precision assessments using plasma samples, which are typical for IVD devices.
- Predicate Devices: The mention of predicate devices (K893524 and K002400) which are also IVD products further supports this classification.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
GJT, GGP
Device Description
HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX 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 IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX 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
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Summary of Performance Studies
Method Comparison: In field site studies evaluating citrated plasma samples, the slopes and correlation coefficients (r) for HemosIL Factor IX Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor IX Deficient Plasma vs. Predicate Hemoliance Factor IX Deficient Plasma on ELECTRA IT Cast ci
IL System: E1600C, n: 65, Slope: 1.0049, r: 0.9584
HemosIL Factor IX Deficient Plasma vs. Predicate IL Test Factor IX Deficient Plasma on ACL Family
IL System: ACL 3000, n: 76, Slope: 1.1076, r: 0.9793
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 (APTT-SP or SynthASil) and both normal and abnormal samples.
ACL 6000: Normal Control, Mean % Factor IX: 102.3, Within run CV%: 5.8, Between Run CV%: 2.6
ACL 6000: Low Abnormal Control, Mean % Factor IX: 24.2, Within run CV%: 8.5, Between Run CV%: 4.1
ACL 9000: Normal Control, Mean % Factor IX: 121.2, Within run CV%: 3.0, Between Run CV%: 3.8
ACL 9000: Low Abnormal Control, Mean % Factor IX: 32.8, Within run CV%: 2.3, Between Run CV%: 5.9
ACL Futura: Normal Control, Mean % Factor IX: 118.2, Within run CV%: 4.4, Between Run CV%: 2.9
ACL Futura: Low Abnormal Control, Mean % Factor IX: 38.2, Within run CV%: 6.0, Between Run CV%: 2.7
ELECTRA 1400C: Normal Control, Mean % Factor IX: 111.5, Within run CV%: 8.4, Between Run CV%: 8.3
ELECTRA 1400C: Low Abnormal Control, Mean % Factor IX: 28.9, Within run CV%: 8.0, Between Run CV%: 7.6
ELECTRA 1800C: Normal Control, Mean % Factor IX: 119.2, Within run CV%: 8.8, Between Run CV%: 5.7
ELECTRA 1800C: Low Abnormal Control, Mean % Factor IX: 30.2, Within run CV%: 8.8, Between Run CV%: 6.4
Key Metrics
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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
Ko3/829
Section 3 HemosIL Factor IX 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:
June 12, 2003
Name of the Device:
HemosIL Factor IX Deficient Plasma
Classification Name(s):
| 864.7290 | Factor Deficiency Tests | Class II |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient |
Identification of Predicate Device(s):
K893524 Hemoliance Factor IX Deficient Plasma on ELECTRA Series Analyzers K002400 IL Test Factor IX Deficient Plasma* on ACL Family of Analyzers *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 IX Deficient Plasma is human plasma immunodepleted of Factor IX and intended for the in vitro diagnostic quantitative determination of Factor IX 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 IX. Correction of the of the deficient plasma is proportional to the concentration (% activity) of the factor IX in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor IX Deficient Plasma is substantially equivalent to Hemoliance Factor IX Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor IX Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3
HemosIL Factor IX Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In field site studies evaluating citrated plasma samples, the slopes and correlation coefficients (r) for HemosIL Factor IX Deficient Plasma versus the predicate devices are shown below:
NOTE: APTT-C and SynthASil were used as the APTT reagents in testing.
HemosIL Factor IX Deficient Plasma vs. Predicate Hemoliance Factor IX Deficient Plasma on ELECTRA IT Cast ci
| IL System | n | Slope | r |
|---|---|---|---|
| E1600C | 65 | 1.0049 | 0.9584 |
HemosIL Factor IX Deficient Plasma vs. Predicate IL Test Factor IX Deficient Plasma on ACL Family
| IL System | n | Slope | r |
|---|---|---|---|
| ACL 3000 | 76 | 1.1076 | 0.9793 |
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 (APTT-SP or SynthASil) and both normal and abnormal samples.
| Instrument | Control | Mean
% Factor IX | Within run
CV% | Between Run
CV% |
|------------------|----------------------|---------------------|-------------------|--------------------|
| ACL 6000 | Normal Control | 102.3 | 5.8 | 2.6 |
| ACL 6000 | Low Abnormal Control | 24.2 | 8.5 | 4.1 |
| ACL 9000 | Normal Control | 121.2 | 3.0 | 3.8 |
| ACL 9000 | Low Abnormal Control | 32.8 | 2.3 | 5.9 |
| ACL Futura | Normal Control | 118.2 | 4.4 | 2.9 |
| ACL Futura | Low Abnormal Control | 38.2 | 6.0 | 2.7 |
| ELECTRA
1400C | Normal Control | 111.5 | 8.4 | 8.3 |
| ELECTRA
1400C | Low Abnormal Control | 28.9 | 8.0 | 7.6 |
| ELECTRA
1800C | Normal Control | 119.2 | 8.8 | 5.7 |
| ELECTRA
1800C | Low Abnormal Control | 30.2 | 8.8 | 6.4 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Ms. Carol Marble Regulatory Affairs Manager JUL 3 1 2003 Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K031829
Trade/Device Name: HemosIL Factor IX Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT, GGP Dated: June 12, 2003 Received: June 13, 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. Iisting 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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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,
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 IX Deficient Plasma
Indications for Use:
HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of factor IX and intended for the in vitro diagnostic quantitative determination of factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Quitte y. Michane C m.D. FOR J. BAPTISTA
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