(41 days)
No
The description focuses on a biological reagent (immunodepleted plasma) used in a standard laboratory assay (PT assay) and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is an in vitro diagnostic intended for quantitative determination of Factor X activity, not for treating a condition.
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 X activity". Additionally, the "Device Description" mentions that it is used for "in vitro diagnostic quantitative determination".
No
The device is a biological reagent (human plasma) used in an in vitro diagnostic test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma".
The "Device Description" also reiterates this: "intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma".
These statements clearly indicate that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
GJT
Device Description
HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X 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 X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X 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 field site studies evaluating citrated plasma samples (normal and abnormal), the slopes and correlation coefficients (r) for HemosIL Factor X Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor X Deficient Plasma vs. Predicate Hemoliance Factor X Deficient Plasma on ELECTRA
IL System: ELECTRA 1600C, n=63, Slope=0.9461, r=0.9948, PT Reagent Used: RecombiPlasTin (K012768)
HemosIL Factor X Deficient Plasma vs. Predicate IL Test Factor X Deficient Plasma on ACL Family
IL System: ACL 3000, n=62, Slope=1.0328, r=0.9849, PT Reagent Used: PT-Fibrinogen Recombinant (K981479)
IL System: ACL Futura, n=62, Slope=1.0680, r=0.9840, PT Reagent Used: PT-Fibrinogen Recombinant (K981479)
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 X: 113.2, Within Run CV%: 3.5, Between Run CV%: 4.6), Low Abnormal Control (Mean % Factor X: 38.9, Within Run CV%: 4.1, Between Run CV%: 6.0)
ACL 6000: Normal Control (Mean % Factor X: 114.0, Within Run CV%: 3.3, Between Run CV%: 4.3), Low Abnormal Control (Mean % Factor X: 29.9, Within Run CV%: 3.0, Between Run CV%: 4.8)
ACL 9000: Normal Control (Mean % Factor X: 117.7, Within Run CV%: 1.4, Between Run CV%: 2.1), Low Abnormal Control (Mean % Factor X: 27.1, Within Run CV%: 1.9, Between Run CV%: 4.4)
ACL Futura: Normal Control (Mean % Factor X: 96.3, Within Run CV%: 4.2, Between Run CV%: 4.5), Low Abnormal Control (Mean % Factor X: 38.9, Within Run CV%: 5.0, Between Run CV%: 6.1)
ELECTRA 1400C: Normal Control (Mean % Factor X: 96.6, Within Run CV%: 0.9, Between Run CV%: 2.9), Low Abnormal Control (Mean % Factor X: 27.5, Within Run CV%: 1.7, Between Run CV%: 2.4)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, correlation coefficients (r), Mean % Factor X, Within Run CV%, Between Run CV%
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 X 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:
April 7, 2003
Name of the Device:
HemosIL Factor X Deficient Plasma
Classification Name(s):
| 864.7290 | Factor Deficiency Tests | Class II |
|---|---|---|
| 81GJT | Plasma, Coagulation Factor Deficient |
Identification of Predicate Device(s):
| K893523 | Hemoliance Factor X Deficient Plasma on ELECTRA Series Analyzers |
|---|---|
| K002400 | IL Test Factor X 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 X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X 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 X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X in the patient plasma, interpolated from a calibration curve.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Factor X Deficient Plasma is substantially equivalent to Hemoliance Factor X Deficient Plasma (on ELECTRA Series Analyzers) and IL Test Factor X Deficient Plasma (on ACL Family of Analyzers) in performance, intended use and safety and effectiveness.
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Section 3 HemosIL Factor X Deficient Plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In field site studies evaluating citrated plasma samples (normal and abnormal), the slopes and correlation coefficients (r) for HemosIL Factor X Deficient Plasma versus the predicate devices are shown below:
HemosIL Factor X Deficient Plasma vs. Predicate Hemoliance Factor X Deficient Plasma on ELECTRA
| IL System | n | Slope | r | PT Reagent Used |
|---|---|---|---|---|
| ELECTRA 1600C | 63 | 0.9461 | 0.9948 | RecombiPlasTin (K012768) |
HemosIL Factor X Deficient Plasma vs. Predicate IL Test Factor X Deficient Plasma on ACL Family
| IL System | an and the first of the first of the first of the first of the first of the first of the first of the first for the first of the first for the first for the first for the fir | Slope | PT Reagent Used | |
|---|---|---|---|---|
| ACL 3000 | 62 | 1.0328 | 0.9849 | PT-Fibrinogen Recombinant (K981479) |
| ACL Futura | 62 | 1.0680 | 0.9840 | PT-Fibrinogen Recombinant (K981479) |
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 X | Within Run
CV% | Between Run
CV% |
|------------------|----------------------|--------------------|-------------------|--------------------|
| ACL 300 | Normal Control | 113.2 | 3.5 | 4.6 |
| | Low Abnormal Control | 38.9 | 4.1 | 6.0 |
| ACL 6000 | Normal Control | 114.0 | 3.3 | 4.3 |
| | Low Abnormal Control | 29.9 | 3.0 | 4.8 |
| ACL 9000 | Normal Control | 117.7 | 1.4 | 2.1 |
| | Low Abnormal Control | 27.1 | 1.9 | 4.4 |
| ACL Futura | Normal Control | 96.3 | 4.2 | 4.5 |
| | Low Abnormal Control | 38.9 | 5.0 | 6.1 |
| ELECTRA
1400C | Normal Control | 96.6 | 0.9 | 2.9 |
| | Low Abnormal Control | 27.5 | 1.7 | 2.4 |
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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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 9 2003
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
K031122 Trade/Device Name: HemosIL Factor X Deficient Plasma Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GJT Dated: April 7, 2003 Received: April 8, 2003
Dear Ms. Marble:
Re:
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 X Deficient Plasma
Indications for Use:
HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X 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)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | K 031122 |
| 510(k) Number |
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
HemosIL Factor X Deficient Plasma 510(k)