(227 days)
Not Found
No
The description focuses on a functional assay measuring clotting time and does not mention any AI/ML components or algorithms.
No
The device is an in vitro diagnostic (IVD) assay designed to aid in the diagnosis of a condition by quantitatively measuring a substance in plasma, rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" states that the device is "an aid in the diagnosis of hereditary and acquired Protein S deficiency". This explicitly indicates its diagnostic purpose.
No
The device is a laboratory assay that measures the functional activity of Protein S in plasma. It is used on specific laboratory instruments (ACL TOP Family members) and involves chemical reactions and measurement of clotting time. This is a reagent-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of free Protein S in human citrated plasma as an aid in the diagnosis of hereditary and acquired Protein S deficiency". This involves testing a sample taken from the human body (in vitro) to provide information for diagnosis.
- Device Description: The description details how the assay works by measuring the prolongation of prothrombin time in the presence of various reagents and a diluted sample of plasma. This is a laboratory-based test performed on a biological sample.
- Sample Type: The assay uses "human citrated plasma," which is a biological sample taken from a human.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma as an aid in the diagnosis of hereditary and acquired Protein S deficiency, on ACL TOP Family members.
Product codes
GGP
Device Description
The HemosIL Protein S Activity assay determines the functional activity of free Protein S by measuring the degree of prolongation of prothrombin time in the presence of the human recombinant factor, phospholipids, calcium ions, and activated Protein C. The protein S activity is correlated with the prolongation of the clotting time of a Protein S deficient plasma to which a diluted sample has been added.
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
Precision Performance characteristics were assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (ACL TOP, ACL TOP 500 CTS and ACL TOP 700). Precision was evaluated in accordance with CLSI EP05-A2-, for 20 days, with 2 runs per day and 2 replicates per run, for each sample level (n=80/ instrument/ lot).
Method Comparison - In-House: An in-house comparison study was performed in accordance with CLSI EPO9-A2; Method Comparison and Bias Estimation, 200 Edition, 2002, to compare the performance of HemoslL Protein S Activity versus the predicate device (HemoslL ProS) on representative ACL TOP Family members.
Method Comparison – Field Sites: Two field site studies were performed to compare the performance of the HemosIL Protein S Activity assay versus the predicate device (HemosIL ProS) on the ACL TOP.
Key Results: The test results demonstrate that the changes in kit composition and tissue factor type do not adversely affect the product's performance.
Key Metrics
ACL TOP Precision (Data from a representative lot):
Normal Control: Mean (% PS) 94.2, CV% (Within run) 2.5, CV% (Total) 4.9
Low Abnormal Control: Mean (% PS) 33.6, CV% (Within run) 3.8, CV% (Total) 7.1
High Abnormal Control: Mean (% PS) 19.3, CV% (Within run) 1.19 (SD), CV% (Total) 2.23 (SD)
Internal Control 1: Mean (% PS) 44.5, CV% (Within run) 2.9, CV% (Total) 6.2
Internal Control 2: Mean (% PS) 67.2, CV% (Within run) 1.7, CV% (Total) 4.7
High Plasma Sample: Mean (% PS) 128, CV% (Within run) 1.6, CV% (Total) 4.2
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows three logos side by side. The first logo is a circular design with horizontal lines, accompanied by the text "Werfen Group" underneath. The second logo is a geometric shape resembling a cube, and the third logo reads "Instrumental Laboratory" in a stacked format.
MAR 1 7 2011
510(k) Summary
(per 21 CFR 807.92)
781-861-4350
781-861-4207
July 28, 2010
HemosIL® Protein S Activity
l. Applicant Contact Information
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 180 Hartwell Road |
| Bedford, MA 01730 | |
| Contact Person: | Jacqueline Emery, BS EE |
Phone Number: Fax Number: Email: Preparation Date:
Device Trade Name
II. Device Regulatory Information
| Regulatory Section | 21 CFR 864.7290 |
|---|---|
| Classification | Class II |
| Common Name: | Protein S Test |
| Classification Name: | Factor Deficiency Test |
| Product Code: | GGP |
| Panel: | 81 (hematology) |
III. Identification of Legally Marketed Device
K053499
HemosIL® ProS
IV. Device Description
The HemosIL Protein S Activity assay determines the functional activity of free Protein S by measuring the degree of prolongation of prothrombin time in the presence of the human recombinant factor, phospholipids, calcium ions, and activated Protein C. The protein S activity is correlated with the prolongation of the clotting time of a Protein S deficient plasma to which a diluted sample has been added.
V. Device Indications/ Intended Use
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma as an aid in the diagnosis of hereditary and acquired Protein S deficiency, on ACL TOP Family members.
1
HemosIL® Protein S Activity Assay
VI. Comparison of Technological Characteristics of the Device
Similarities
ﺘ
The HemosIL Protein S Activity Assay is Substantially Equivalent to its predicate, the HemosIL ProS Assay (K053499), in both intended use and performance:
| TABLE 1: | Table of Similarity and Differences |
|---|---|
| ---------- | ------------------------------------- |
| Item | Predicate Device | New Device |
|---|---|---|
| K# | K053499 | TBD |
| Device Name | HemosIL ProS | HemosIL Protein S |
| Activity | ||
| Manufacturer | Instrumentation Laboratory Co. (self) | Same |
| Indications for Use | Automated coagulation functional assay | |
| for the quantitative determination of | ||
| free Protein S in human citrated plasma | ||
| as an aid in the diagnosis of hereditary | ||
| and acquired Protein S deficiency, on | ||
| the ACL TOP® Family of analyzers. | Same | |
| Sample Type | citrated plasma | Same |
| Test Principle | Functional Clotting Assay | Same |
| Methodology | The test is based on the ability of | |
| endogenous protein S as a cofactor of | ||
| activated protein C to prolong the | ||
| clotting time. Protein S levels in patient | ||
| plasma are measured automatically on | ||
| the ACL TOP® Family of analyzers. |
The test determines the functional
activity of free protein S by measuring
the degree of prolongation of a
prothrombin time in the presence of
the recombinant tissue factor,
phospholipids, calcium ions, and
activated protein C.
The protein S activity is correlated with
the prolongation of the clotting time of
a Protein S deficient plasma to which
diluted sample has been added. | Same |
| Calibration | HemosIL Calibration plasma values are
assigned for Protein S Activity and used
for calibrating the standard curve. | Same |
| Item | Predicate Device | New Device |
| K# | K053499 | TBD |
| Device Name | HemosIL ProS | HemosIL Protein S
Activity |
| Kit Composition | | |
| - Protein S reagent | - Lyophilized preparation
containing recombinant tissue
factor, synthetic phospholipids,
activated protein C, Polybrene,
buffer, stabilizers &
preservatives.
- Includes calcium ions.
- Rabbit Tissue Factor | - Lyophilized
preparation
containing
recombinant
tissue factor,
synthetic
phospholipids,
activated protein
. C, Polybrene,
buffer, stabilizers
& preservatives. - Calcium is added
separately to
improve shelf life. - Human Tissue
Factor |
| - Calcium Reagent | - Calcium is included in the Protein
S reagent vial. | - Calcium is
included in a
separate vial. |
| - Protein S deficient
plasma | - Lyophilized human plasma which
has been artificially depleted of
protein S. | - Same except for
vial size. |
| - Protein S control
plasma | - Lyophilized human plasma
containing a low level of protein S. | - Not sold with this
product. |
2
TABLE 2: Table of Similarity and Differences (continued)
Differences
. . .
There are 2 main differences between the 2 products; the HemosIL Protein S Activity Assay, the subject of this submission, and its HemosIL ProS assay predicate: the applicant contains human tissue factor, whereas the predicate utilizes rabbit tissue factor.
In addition the HemosiL Protein S Activity assay kit composition has changed as compared to its predicate: the calcium ions required for the reaction, which were previously included in the predicate's Protein S reagent vial, are now offered as a separate component. The test results demonstrate that these changes do not adversely affect the product's performance.
3
VII. Summary of Performance Data
. Precision
Performance characteristics were assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (ACL TOP, ACL TOP 500 CTS and ACL TOP 700). Precision was evaluated in accordance with CLSI EP05-A2-, for 20 days, with 2 runs per day and 2 replicates per run, for each sample level (n=80/ instrument/ lot). Data from a representative lot is included below:
| ACL TOP | Mean (% PS) | CV% (Within run) | CV% (Total) |
|---|---|---|---|
| · Normal Control | 94.2 | 2.5 | 4.9 |
| Low Abnormal Control | 33.6 | 3.8 | 7.1 |
| High Abnormal Control | 19.3 | 1.19(SD) | 2.23 (SD) |
| Internal Control 1 | 44.5 | 2.9 | 6.2 |
| Internal Control 2 | 67.2 | 1.7 | 4.7 |
| High Plasma Sample | 128 | 1.6 | 4.2 |
- . Method Comparison - In-House
An in-house comparison study was performed in accordance with CLSI EPO9-A2; Method Comparison and Bias Estimation, 200 Edition, 2002, to compare the performance of HemoslL Protein S Activity versus the predicate device (HemoslL ProS) on representative ACL TOP Family members with the following results:
TABLE 3: METHOD COMPARISON RESULTS IN-HOUSE
|
System | Canada Canada Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara | 1
Slope | E & TE I RE IN MIN LA MINING BANK |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------
| | 1
0.966 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Achieves and color de control controlled and contraction of the contribution
0 000 |
| CI TOP SOO CTS | | BALL BROOM STATIST A
OAC
A AND A AND A Comen | 1975
| 44-46-140 |
|---|
CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline, 2" edition.
4
Method Comparison – Field Sites .
Two field site studies were performed to compare the performance of the HemosIL Protein S Activity assay versus the predicate device (HemosIL ProS) on the ACL TOP with the following 1 results:
| TABLE 4: | METHOD COMPARISON RESULTS FIELD SITE | |
|---|---|---|
| -- | ---------- | -------------------------------------- |
|
System | | Slope | -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ﻟ
44 1
| A A C
1 | 0000 | Address States
U OCC |
| 11 m
t | A 1999 199
Acres of the comments of the closed on the comments of the contributed to the courses
A ANNUAL AND AND AND A | 1 010 | 1
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ما تي مل هال |
VIII. Conclusion
Based on the device's similarity in intended use, technology characteristics and performance data, it is determined that the IL HemosIL Protein S Activity assay is substantially equivalent to its predicate, the HemosIL ProS assay.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Instrumentation Laboratory Co. c/o Ms. Jacqueline Emery Regulatory Affairs Manager 180 Hartwell Rd. Bedford, MA 01730
MAR 1 7 2011
Re: K102164 Trade/Device Name: HemosIL® Protein S Activity Regulation Number: 21 CFR 864.7290 Regulation Name: Test Qualitative and Quantitative Factor Deficiency Regulatory Class: Class II Product Code: GGP Dated: March 4, 2011 Received: March 7, 2011
Dear Ms. Emery,
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
6
Page 2 - Ms. Jacqueline Emery
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M. Khan
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
K102164 - HemosIL® Protein S Activity Assay
09/28/2010 Request for Additional Information-Response
Indications for Use Statement
102164 510(k) Number (if known):
Device Name: HemosIL Protein S Activity
Indications for Use:
Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma as an aid in the diagnosis of hereditary and acquired Protein S deficiency, on the ACL TOP Family of analyzers.
V 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)
Lenck
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102164
COMPANY CONFIDENTIAL