(56 days)
Not Found
No
The summary describes a diagnostic reagent and its performance in a standard laboratory assay (APTT) on existing coagulation analyzers. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making. The method relies on interpolation from a calibration curve, a traditional analytical technique.
No
This device is for in vitro diagnostic quantitative determination, not for treating or preventing disease.
Yes
The device is described as "intended for the in vitro diagnostic quantitative determination of factor XII activity".
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 statement explicitly says "intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma". This clearly indicates the device is used outside of the body to diagnose a condition (abnormal factor XII activity).
- Device Description: The description further elaborates on how the device is used to determine factor XII activity in patient plasma, which is a laboratory test performed in vitro.
- Performance Studies: The performance studies describe method comparisons and precision testing, which are typical evaluations for IVD devices to demonstrate their analytical performance.
N/A
Intended Use / Indications for Use
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
GJT
Device Description
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII 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 XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor XII 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 an in-house method comparison study evaluating approximately 70 citrated plasma samples, the slopes and correlation coefficients (r) for HemosIL Factor XII Deficient Plasma versus the predicate devices are shown below:
New HemosIL Factor XII Deficient Plasma vs. Predicate HemosIL Factor XII Deficient Plasma on ACL Family:
IL System: ACL 3000, n: 71, Slope: 0.9284, r: 0.9882
IL System: ACL 10000, n: 71, Slope: 0.9116, r: 0.9704
IL System: ACL Advance, n: 70, Slope: 1.0065, r: 0.9687
IL System: ACL TOP, n: 72, Slope: 1.0739, r: 0.9551
New HemosIL Factor XII Deficient Plasma vs. Predicate Hemoliance Factor XII Deficient Plasma on ELECTRA:
IL System: E1600C, n: 73, Slope: 0.9918, r: 0.9863
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 and SynthASil) and both normal and abnormal controls.
Instrument: ACL 9000, Control: Normal Control, Mean % Factor XII: 100.0, Within run %CV: 1.9, Between Run %CV: 3.4
Instrument: ACL 9000, Control: Special Test Control Level 2, Mean % Factor XII: 30.4, Within run %CV: 2.6, Between Run %CV: 3.3
Instrument: ACL Futura, Control: Normal Control, Mean % Factor XII: 95.1, Within run %CV: 3.0, Between Run %CV: 2.9
Instrument: ACL Futura, Control: Special Test Control Level 2, Mean % Factor XII: 31.4, Within run %CV: 2.3, Between Run %CV: 3.8
Instrument: ACL TOP, Control: Normal Control, Mean % Factor XII: 103.0, Within run %CV: 4.7, Between Run %CV: 3.1
Instrument: ACL TOP, Control: Special Test Control Level 2, Mean % Factor XII: 33.9, Within run %CV: 6.1, Between Run %CV: 3.2
Instrument: ELECTRA 1600C, Control: Normal Control, Mean % Factor XII: 102.4, Within run %CV: 3.4, Between Run %CV: 7.8
Instrument: ELECTRA 1600C, Control: Special Test Control Level 2, Mean % Factor XII: 36.0, Within run %CV: 3.5, Between Run %CV: 4.3
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 XII Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
December 14, 2004
Name of the Device:
HemosIL Factor XII Deficient Plasma
Regulatory Information:
| Regulation Section: | Factor Deficiency Test (864.7290) |
|---|---|
| Classification: | Class II |
| Product Code: | GJT |
| Panel: | Hematology |
Identification of Predicate Device(s):
| K893534 | Hemoliance Factor XII Deficient Plasma on ELECTRA Series Analyzers |
|---|---|
| K002400 | HemosIL Factor XII Deficient Plasma* on ACL Family of Analyzers |
| *NOTE: FDA cleared as part of the each ACL instrument 510(k): for | |
| example, the ACL Advance (K002400) |
Description of the Device/Intended Use(s):
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII 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 XII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor XII in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The new HemosIL Factor XII Deficient Plasma is substantially equivalent to Hemoliance Factor XII Deficient Plasma (on ELECTRA Series Analyzers) and HemosIL Factor XII Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3 HemosIL Factor XII Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In an in-house method comparison study evaluating approximately 70 citrated plasma samples, the slopes and correlation coefficients (r) for HemosIL Factor XII Deficient Plasma versus the predicate devices are shown below:
NOTE: HemosIL APTT-SP and SynthASil were used as the APTT reagents in testing.
New HemosIL Factor XII Deficient Plasma vs. Predicate HemosIL Factor XII Deficient Plasma on ACL Family
| IL System | n | Slope | r |
|---|---|---|---|
| ACL 3000 | 71 | 0.9284 | 0.9882 |
| ACL 10000 | 71 | 0.9116 | 0.9704 |
| ACL Advance | 70 | 1.0065 | 0.9687 |
| ACL TOP | 72 | 1.0739 | 0.9551 |
New HemosIL Factor XII Deficient Plasma vs. Predicate Hemoliance Factor XII Deficient Plasma on ELECTRA
| IL System | n | Slope | r |
|---|---|---|---|
| E1600C | 73 | 0.9918 | 0.9863 |
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 and SynthASil) and both normal and abnormal controls.
| Instrument | Control | Mean
% Factor XII | Within run
%CV | Between Run
%CV |
|------------------|------------------------------|----------------------|-------------------|--------------------|
| ACL 9000 | Normal Control | 100.0 | 1.9 | 3.4 |
| ACL 9000 | Special Test Control Level 2 | 30.4 | 2.6 | 3.3 |
| ACL Futura | Normal Control | 95.1 | 3.0 | 2.9 |
| ACL Futura | Special Test Control Level 2 | 31.4 | 2.3 | 3.8 |
| ACL TOP | Normal Control | 103.0 | 4.7 | 3.1 |
| ACL TOP | Special Test Control Level 2 | 33.9 | 6.1 | 3.2 |
| ELECTRA
1600C | Normal Control | 102.4 | 3.4 | 7.8 |
| ELECTRA
1600C | Special Test Control Level 2 | 36.0 | 3.5 | 4.3 |
HemosIL Factor XII Deficient Plasma 510(k)
2
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
FEB - 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K043459
Trade/Device Name: HemosIL Factor XII Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Plasma, coagulation deficient Regulatory Class: II Product Code: GJT Dated: December 14, 2004 Received: December 15, 2004
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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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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology 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): ____________________________________________________________________________________________________________________________________________________
Device Name: HemosIL Factor XII Deficient Plasma
Indications for Use:
HemosIL Factor XII Deficient Plasma is human plasma immunodepleted of factor XII and intended for the in vitro diagnostic quantitative determination of factor XII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-
(21 CFR 8
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043459
HemosIL Factor XII Deficient Plasma 510(k)