(153 days)
Not Found
No
The summary describes a standard automated laboratory analyzer with software updates primarily for operating system compatibility and ease-of-use enhancements. There is no mention of AI, ML, image processing, or any data-driven learning components.
No.
The "Intended Use / Indications for Use" section states that the device is "designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing". It is an analyzer for diagnostic purposes, not a device that provides therapy or treatment.
Yes
The device is described as an "in vitro diagnostic clinical use" analyzer, providing "results for both direct hemostasis measurements and calculated parameters" for the assessment of thrombosis and/or hemostasis. This indicates its role in diagnosing medical conditions related to blood clotting.
No
The device description explicitly states that the ACL TOP is a "bench top, fully automated, random access analyzer," which is a physical hardware device. The software described is an update to the operating system and includes additional features for this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement clearly identifies the device's purpose as being for in vitro diagnostic use.
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 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.
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
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.
K063679 ACL TOP
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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ACL TOP System Software V3.0.0 510(k) Summary
Applicant Contact Information:
MAY 1 4 2008
| Applicant:
Address: | Instrumentation Laboratory Co.
113 Hartwell Avenue
Lexington, MA 02421 |
|-------------------------------------------------|------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number: | Carol Marble, Regulatory Affairs Director
781-861-4467
781-861-4207 |
| Preparation Date: | February 4, 2008 |
Device Trade Name:
ACL TOP
Regulatory Information:
| Regulation Section: | Coagulation Instrument (864.5400) |
|---|---|
| Classification: | Class II |
| Product Code: | GKP |
| Panel: | Hematology |
Predicate Device:
K063679 ACL TOP
Device Intended Use / Description:
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.
Reason for Submission:
System Software V3.0.0 is being introduced on the ACL TOP family (instrument available with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System. This software also includes additional features and ease-of-use enhancements.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679).
- There are no changes in the ACL TOP test parameters (which are separate from the . system software) and therefore, no changes to the labeled indications for use/intended use or performance claims of either the instrument or its reagents.
1
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2008
Instrumentation Laboratory Co. C/O Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K073377
Trade/Device Name: ACL TOP (with System Software V3.0.0) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: November 30, 2007 Received: December 3, 2007
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
2
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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K073377 510(k) Number (if known): ___
Device Name: ACL TOP Family
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.
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)
Auyline Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073377