(51 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 "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as being for "in vitro diagnostic quantitative determination of factor VIII activity," indicating it is an in vitro diagnostic (IVD) device used for laboratory testing, not for direct therapeutic intervention on a patient.
Yes
This device is intended for the in vitro diagnostic quantitative determination of factor VIII activity, which is a diagnostic purpose.
No
The device is a biological reagent (human plasma) used in an in vitro diagnostic assay, not a software program.
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 VIII activity in citrated plasma".
- Device Description: The description reiterates its use for "in vitro diagnostic quantitative determination of factor VIII activity".
- Mechanism: The description explains how it is used in vitro (outside the body) to analyze a patient sample (citrated plasma) to determine a specific biological marker (factor VIII activity).
- Performance Studies: The performance studies involve testing the device with "citrated plasma samples" and comparing the results to predicate devices, which is typical for IVD validation.
The core function of the device is to analyze a biological sample in vitro to provide diagnostic information about a patient's condition (factor VIII activity). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Product codes (comma separated list FDA assigned to the subject device)
GJT
Device Description
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII 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 approximately 60 citrated plasma samples (30 normal and 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VIII Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor VIII Deficient Plasma vs. Predicate Hemoliance Factor VIII Deficient Plasma on ELECTRA
IL System: E1400C, n: 59, Slope: 0.9518, r: 0.9873
HemosIL Factor VIII Deficient Plasma vs. Predicate IL Test Factor VIII Deficient Plasma on ACL Family
IL System: ACL 300, n: 60, Slope: 0.9391, r: 0.9942
IL System: ACL Advance, n: 63, Slope: 1.0073, r: 0.9906
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 samples.
ACL 9000:
Normal Control: Mean % Factor VIII 72.6, Within run CV% 3.1, Between Run CV% 3.1
Low Abnormal Control: Mean % Factor VIII 32.2, Within run CV% 2.2, Between Run CV% 3.3
ACL Futura:
Normal Control: Mean % Factor VIII 78.3, Within run CV% 2.7, Between Run CV% 3.6
Low Abnormal Control: Mean % Factor VIII 31.5, Within run CV% 3.4, Between Run CV% 4.0
ELECTRA 1600C:
Normal Control: Mean % Factor VIII 93.9, Within run CV% 4.8, Between Run CV% 6.0
Low Abnormal Control: Mean % Factor VIII 37.2, Within run CV% 4.1, Between Run CV% 4.6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K893525 Hemoliance Factor VIII Deficient Plasma, K002400 IL Test Factor VIII 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.
Not Found
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).
0
Section 3 HemosIL Factor VIII 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 Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
December 23, 2003
Name of the Device:
HemosIL Factor VIII Deficient Plasma
Classification Name(s):
| 864.7290 Factor Deficiency Tests | Class II | |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient |
Identification of Predicate Device(s):
- K893525 Hemoliance Factor VIII Deficient Plasma on ELECTRA Series Analyzers
- K002400 IL Test Factor VIII 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 VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor VIII Deficient Plasma is substantially equivalent to Hemoliance Factor VIII Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor VIII Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
1
Section 3 HemosIL Factor VIII 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 and 30 abnormal), the slopes and correlation coefficients (r) for HemosIL Factor VIII Deficient Plasma versus the predicate devices are shown below:
NOTE: APTT-SP and SynthASil were used as the APTT reagents in testing.
HemosIL Factor VIII Deficient Plasma vs. Predicate Hemoliance Factor VIII Deficient Plasma on ELECTRA
| IL System | n | Slope | r |
|---|---|---|---|
| E1400C | 59 | 0.9518 | 0.9873 |
HemosIL Factor VIII Deficient Plasma vs. Predicate IL Test Factor VIII Deficient Plasma on ACL Family
| IL System | n | Slope | r |
|---|---|---|---|
| ACL 300 | 60 | 0.9391 | 0.9942 |
| ACL Advance | 63 | 1.0073 | 0.9906 |
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 samples.
| Instrument | Control | Mean
% Factor VIII | Within run
CV% | Between Run
CV% |
|------------------|----------------------|-----------------------|-------------------|--------------------|
| ACL 9000 | Normal Control | 72.6 | 3.1 | 3.1 |
| ACL 9000 | Low Abnormal Control | 32.2 | 2.2 | 3.3 |
| ACL Futura | Normal Control | 78.3 | 2.7 | 3.6 |
| ACL Futura | Low Abnormal Control | 31.5 | 3.4 | 4.0 |
| ELECTRA
1600C | Normal Control | 93.9 | 4.8 | 6.0 |
| ELECTRA
1600C | Low Abnormal Control | 37.2 | 4.1 | 4.6 |
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Re:
FEB 1 3 2004
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
K034007 Trade/Device Name: HemosIL Factor VIII Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Plasma, Coagulation Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: December 23, 2003 Received: December 24, 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 I'DA 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.
3
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,
Joseph L. Arblett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices 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): Kø 3 4007
Device Name: HemosIL Factor VIII Deficient Plasma
Indications for Use:
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 | |||
| Office of In Vitro Diagnostic Device | |||
| Evaluation and Safety | |||
| 510(k) | K034007 | ||
| Prescription Use | OR | Over-The-Counter Use |
Section 2 HemosIL Factor VIII Deficient Plasma 510(k) Page 1 of 1