(62 days)
Not Found
No
The summary describes a standard in vitro diagnostic reagent kit for coagulation testing and does not mention any AI/ML components or capabilities.
No.
The device is an in vitro diagnostic (IVD) tool used for determining Activated Partial Thromboplastin Time (APTT) to evaluate coagulation pathways and monitor heparin therapy; it does not directly treat or provide therapy to a patient.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro diagnostic determination" and for "general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy." This indicates its use in diagnosing or monitoring patient conditions.
No
The device is an in vitro diagnostic reagent (IL Test™ APTT-SP) used on IL Coagulation Systems, which are hardware devices. The summary describes performance studies related to the reagent and its use on these systems, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma". The phrase "in vitro diagnostic" is a direct indicator.
- Device Description: The description reiterates "intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT)".
- Nature of the Test: The APTT test is a laboratory test performed on a blood sample (citrated plasma) to assess blood clotting. This is a classic example of an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
Product codes
GFO
Device Description
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems.
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
In a method comparison study evaluating 73 plasma samples (50 abnormal/23 normal), the correlation (r) of the new IL Test™ APTT-SP to the predicate IL Test™ APTT-C on the ACL 300 was 0.915 and on the ACL Futura was 0.907. On the ACL 300, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.27 seconds), 0.89% (at a mean of 52.05 seconds) and 1.32% (at a mean of 74.65 seconds). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.50 seconds), 0.84% (at a mean of 50.89 seconds) and 0.93% (at a mean of 72.38 seconds).
Key Metrics
Correlation (r) of 0.915 and 0.907.
CV of 0.65%, 0.89%, 1.32%, 0.65%, 0.84%, 0.93%.
Predicate Device(s)
K881367, K871973, K924098, K951891, K961991
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
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SECTION 3 IL Test™ APTT-SP - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
NOV - 4 1997
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4467 (617) 861-4464 Fax:
Contact Persons:
Carol Marble Phone: (617) 861-4467 Alternate: Betty Lane Phone: (617) 861-4182
Summary Prepared:
September 2, 1997
Name of the device:
IL Test™ APTT-SP
Classification name(s):
| 864.7925 | Partial Thromboplastin Time Tests |
|---|---|
| 81 GFO | Activated Partial Thromboplastin |
Identification of predicate device(s):
IL Test™ APTT-C
K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer
Class II
Description of the device/intended use(s):
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
IL Test™ APTT-SP uses the same test principle as the predicate IL Test™ APTT-C and is substantially equivalent in performance, intended use, and safety and effectiveness.
Summary of Performance Data:
In a method comparison study evaluating 73 plasma samples (50 abnormal/23 normal), the correlation (r) of the new IL Test™ APTT-SP to the predicate IL Test™ APTT-C on the ACL 300 was 0.915 and on the ACL Futura was 0.907. On the ACL 300, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.27 seconds), 0.89% (at a mean of 52.05 seconds) and 1.32% (at a mean of 74.65 seconds). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.50 seconds), 0.84% (at a mean of 50.89 seconds) and 0.93% (at a mean of 72.38 seconds).
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Requlatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
NOV - 4 1997
K973306 Re: IL Test™ APTT-SP Trade Name: Requlatory Class: II Product Code: GFO Dated: September 2, 1997 September 3, 1997 Received:
Dear Ms. Marble:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices); please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: IL Test™ APTT-SP
Indications for Use:
IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
(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 Services | |
| 510(k) Number | K973360 |
| Prescription Use (Per 21 CFR 801.019) | |
|---|---|
| --------------------------------------- | -- |
OR Over-The-Counter Use
| Section 2 | IL Test™ APTT-SP 510(k) | Page 1 of 1 |
|---|---|---|
| ----------- | ------------------------- | ------------- |