(28 days)
No
The summary describes a functional assay for determining Protein S levels and mentions revisions to stability claims based on internal QC data. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic assay used for the quantitative determination of free Protein S in human plasma as an aid in diagnosis, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that HemosIL ProS is "as an aid in the diagnosis of hereditary and acquired Protein S deficiency." This directly indicates its role in diagnosis.
No
The device is an in vitro diagnostic assay, which is a reagent kit used with specific hardware (IL coagulation systems), not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic test determines the functional activity of free Protein S..."
This clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.
Product codes
GGP
Device Description
HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
The reconstituted and onboard stability claims for HemosIL ProS on the ACL Futura (K951891) and ACL Advance (K002400) are being revised as a precautionary measure based on indications from internal QC release data on multiple product lots.
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
Prescription Use
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
Based on additional stability testing on the ACL Futura/ACL Advance, we are revising the onboard claim to 1 hour and the reconstituted 2-8℃ claim to 12 hours to ensure the optimal integrity of the product in the field.
All other performance testing was within specification and is consistent with the currently labeled claims in the product insert for HemosIL ProS.
Key Metrics
Not Found
Predicate Device(s)
K011424 HemosIL ProS
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
JAN 1 3 2006 Section 3
HemosIL ProS 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:
December 15, 2005
Name of the Device:
HemosIL ProS
Classification Name:
864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficiency
Identification of Predicate Device(s):
K011424 HemosIL ProS
Description of the Modified Device:
HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
The reconstituted and onboard stability claims for HemosIL ProS on the ACL Futura (K951891) and ACL Advance (K002400) are being revised as a precautionary measure based on indications from internal QC release data on multiple product lots.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of HemosIL ProS with modified stability claims for the ACL Futura and ACL Advance is not materially different from the FDA cleared device.
Summary of Performance Data:
Based on additional stability testing on the ACL Futura/ACL Advance, we are revising the onboard claim to 1 hour and the reconstituted 2-8℃ claim to 12 hours to ensure the optimal integrity of the product in the field.
All other performance testing was within specification and is consistent with the currently labeled claims in the product insert for HemosIL ProS.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
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
JAN 1 3 2006
Re: K053499
Trade/Device Name: HemosIL ProS Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor deficiency test Regulatory Class: II Product Code: GGP Dated: December 15, 2005 Received: December 20, 2005
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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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,
lobetz Beckerh
Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K053499
Device Name: HemosIL ProS
Indications for Use:
HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.
This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Division/Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
Special 510(k): HemosIL ProS