(30 days)
Not Found
No
The summary describes a standard automated coagulation analyzer and does not mention any AI or ML capabilities.
No
The device is an in vitro diagnostic analyzer used for testing in the hemostasis laboratory, not for treating or rehabilitating patients.
Yes
The device is "designed specifically for in vitro diagnostic clinical use" and "provides results for both direct hemostasis measurements and calculated parameters," which are used in the assessment of thrombosis and/or hemostasis. These functions are characteristic of a diagnostic device.
No
The device description explicitly states it is a "bench top, fully automated, random access analyzer" and a "fully automated coagulation analyzer," indicating it is a physical hardware device with integrated software, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed specifically for in vitro diagnostic clinical use".
- Device Description: The description further clarifies that it's a "fully automated coagulation analyzer" used for "coagulation and/or fibrinolysis testing". These are laboratory tests performed on samples taken from the body, which is the definition of in vitro diagnostics.
- Intended User / Care Setting: The intended user is described as being in the "hemostasis laboratory", which is a clinical laboratory setting where in vitro diagnostic tests are performed.
The combination of these points clearly indicates that the ACL TOP is intended for use in performing diagnostic tests on biological samples outside of the body, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
Product codes (comma separated list FDA assigned to the subject device)
GKP
Device Description
The ACL TOP Family are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family.
The ACL TOP Family instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family:
Coagulometric (Turbidimetric) Measurements Chromogenic (Absorbance) Measurements Immunological Measurements
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
in vitro diagnostic clinical use in the hemostasis laboratory
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Instrumentation Laboratory (IL) Co. Nikita Malladi Regulatory Affairs Specialist II 180 Hartwell Road Bedford, MA 01730
Re: K160276
Trade/Device Name: ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: February 1, 2016 Received: February 2, 2016
Dear Ms. Malladi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner S
For Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
ACL TOP (ACL TOP 700; ACL TOP 700 CTS; ACL TOP 700 LAS; ACL TOP 500 CTS; ACL TOP 300 CTS)
Indications for Use (Describe)
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
| Submitter's Information | Instrumentation Laboratory (IL) Co.
180 Hartwell Road
Bedford, MA 01730, USA |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Nikita Malladi, Regulatory Affairs Specialist II
Phone: 781-674-3245
Fax: 781-861-4207
Email: nmalladi@ilww.com |
| Preparation Date | February 24, 2016 |
| Device Trade Name | ACL TOP:
ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS |
| Regulatory Information | Classification: Class II
Regulation No.: 21 CFR 864.5400
Common Name: Coagulation Instrument
Panel: Hematology (81)
Product Code: GKP |
| Predicate Device | ACL TOP: K073377; K091980 (LAS model) |
| Device Indications for Use /
Intended Use | The ACL TOP is a bench top, fully automated, random access
analyzer designed specifically for in vitro diagnostic clinical use in
the hemostasis laboratory for coagulation and/or fibrinolysis testing
in the assessment of thrombosis and/or hemostasis. The system
provides results for both direct hemostasis measurements and
calculated parameters. |
| Device Description | The ACL TOP Family are fully automated coagulation analyzers that
utilize the same intuitive software, the same consumables,
reagents, calibrators and controls, and provide the same analytical
methodology for routine and specialty assay result reporting as the
predicate ACL TOP Family.
The ACL TOP Family instrument performs the following types of
tests, using the same optical measuring wavelengths and test
parameters as the predicate ACL TOP Family:
Coagulometric (Turbidimetric) Measurements Chromogenic (Absorbance) Measurements Immunological Measurements |
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Comparison to Predicate:
This Special 510(k) is being submitted to switch the operating system from Windows XP to Windows 7 for ACL TOP Family Instruments.
The submission meets the criteria for a Special 510(k) based on the following:
- No change in indications for use or intended use
- No change in operating principle ●
- No change to labeled performance claims, for the instrument family of the associated reagents
- No change to hardware
- No change to data reduction software
- No change to test parameters
- No change to calibration ●
- No change to quality controls
- No change to consumables
- No change to reagents
Following is a description of the similarities and differences between the currently marketed ACL TOP Family (K073377, K091980 (LAS model) ) and ACL TOP Family with the Software 5. 3 update:
| Item | Predicate | Updated Device (with SW 5.3) |
|---|---|---|
| Trade Names | ACL TOP ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS | ACL TOP ACL TOP 700 ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS |
| Indications for Use | The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. | |
| The system provides results for both direct hemostasis measurements and calculated parameters. | Same | |
| Matrix | 3.2% Citrated Plasma | Same |
| Methodology | The ACL TOP Family performs the following types of tests: Coagulometric (Turbidimetric) Measurements (405 nm or 671 nm) Chromogenic (Absorbance) Measurements (405 nm) Immunological Measurements (405 nm or 671 nm) | Same |
| Test Menu | Clotting, chromogenic and immunological assays | Same |
| Quality Control | Automated QC | Same |
| Software | ||
| (Operating System) | Windows XP | Windows 7 |
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Conclusion:
Based on the shared indications for use, operating principle, consumables, reagents, controls and calibrators, the ACL TOP Family with software v5.3 running on the Windows 7 operating system can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, ACL TOP Family.