(29 days)
No
The summary describes a reagent for a standard laboratory test (APTT) and its performance characteristics. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation.
No.
This device is an in vitro diagnostic reagent used to determine APTT in human plasma, which evaluates the intrinsic coagulation pathway and monitors heparin therapy. It is not directly applied to the body for therapeutic purposes.
Yes.
Explanation: The device is used for the "in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma" which is "used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy." These uses are diagnostic in nature, as they provide information about a patient's physiological state to aid in diagnosis or monitoring of a condition.
No
The device is described as a reagent for in vitro determination of APTT, which is a chemical substance used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma". The phrase "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also specifies the sample type (human citrated plasma) and the analyte being measured (APTT).
- Device Description: The description reiterates the "in vitro determination" of APTT in human citrated plasma.
- Purpose: The product is used for evaluating the intrinsic coagulation pathway, APTT substitution tests, and monitoring heparin therapy. These are all diagnostic purposes performed on biological samples outside the body.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Product codes
GFO
Device Description
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
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)
Within run and total precision assessed over multiple runs using three levels of control plasma for APTT gave the following results:
Normal: Mean (Seconds) 28.5, CV% (Within run) 0.6, CV% (Total) 0.6
Low Abnormal: Mean (Seconds) 49.0, CV% (Within run) 0.8, CV% (Total) 0.9
High Abnormal: Mean (Seconds) 62.5, CV% (Within run) 0.7, CV% (Total) 0.8
In a method comparison study evaluating citrated plasma samples, the slopes and correlations coefficient (r) are shown below for four different lots of the legally marketed HemosLL SynthASil tested on an ACL Advance with optimized APTT parameters versus on the ACL TOP:
SynthASil Lot A: n 93, Slope 1.011, Intercept -0.664, r 0.9979, Sample Range (Sec.) 25.6 - 188.6
SynthASil Lot B: n 93, Slope 0.984, Intercept 0.293, r 0.9987, Sample Range (Sec.) 27.0 - 220.1
SynthASil Lot C: n 93, Slope 0.994, Intercept 0.159, r 0.9976, Sample Range (Sec.) 25.7 - 228.1
SynthASil Lot D: n 92, Slope 0.973, Intercept 1.260, r 0.9973, Sample Range (Sec.) 27.4 - 204.8
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
APR 1 3 2006
510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone No .: 781-861-4467 Fax No .: 781-861-4207
Prepared:
March 14, 2006
Device Name:
HemosIL SynthASil
Regulatory Information:
| Regulation No.: | 864.7925 |
|---|---|
| Classification Name: | Partial Thromboplastin Time Tests |
| Product Code: | GFO |
| Panel: | Hematology |
Predicate Device:
K953981 HemosIL SynthASil
Device Description:
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Reason for Submission:
The APTT parameter settings for HemosIL SynthASil on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of HemosIL SynthASil with optimized APTT parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414).
1
510(k) Summary (Cont.) (Summary of Safety and Effectiveness)
Summary of Performance Data:
Within Run Precision
Within run and total precision assessed over multiple runs using three levels of control plasma for APTT gave the following results:
| Mean (Seconds) | CV% (Within run) | CV% (Total) | |
|---|---|---|---|
| Normal | 28.5 | 0.6 | 0.6 |
| Low Abnormal | 49.0 | 0.8 | 0.9 |
| High Abnormal | 62.5 | 0.7 | 0.8 |
Method Comparison
In a method comparison study evaluating citrated plasma samples, the slopes and correlations coefficient (r) are shown below for four different lots of the legally marketed HemosLL SynthASil tested on an ACL Advance with optimized APTT parameters versus on the ACL TOP:
| SynthASil Lot | n | Slope | Intercept | r | Sample Range (Sec.) |
|---|---|---|---|---|---|
| Lot No. A | 93 | 1.011 | -0.664 | 0.9979 | 25.6 - 188.6 |
| Lot No. B | 93 | 0.984 | 0.293 | 0.9987 | 27.0 - 220.1 |
| Lot No. C | 93 | 0.994 | 0.159 | 0.9976 | 25.7 - 228.1 |
| Lot No. D | 92 | 0.973 | 1.260 | 0.9973 | 27.4 - 204.8 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "U.S. Department of Health & Human Services USA" in a circular pattern.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125
K060688 Trade/Device Name: HemosIL SynthASil Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GFO Dated: March 14, 2006 Received: March 15, 2006
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.
APR 1 3 2006
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,
lobatz Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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 SynthASil -- Optimized Parameter Settings on the ACL Futura/ACL Advance
Indications for Use:
HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bruntidin
Director of Staff
Office of In Vitro Diagnostic Device Evaluation and Safety