(28 days)
No
The summary describes a fully automated coagulation analyzer with pre-analytical features for detecting potential interferences (HIL, underfilled tubes, clogs). While automated, there is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making beyond simple rule-based alerts. The focus is on analytical methodology and pre-analytical checks, not learning or adaptive capabilities.
No
The device is an in vitro diagnostic analyzer used for testing in the hemostasis laboratory to assess thrombosis and hemostasis, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "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 directly indicates its diagnostic purpose.
No
The device description explicitly states it is a "fully automated coagulation analyzer" and mentions performing tests using "optical measuring wavelengths," indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the devices are "designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory".
- Testing Type: The device performs "coagulation and/or fibrinolysis testing", which are tests performed on biological samples (like blood) outside of the body to diagnose or monitor medical conditions.
- Sample Type: The description mentions analyzing "sample tubes", indicating the use of biological samples.
- Clinical Use: The intended use is for "clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis", which is a clear indication of diagnostic application.
N/A
Intended Use / Indications for Use
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide 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 50 Series 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 50 Series 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
The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).
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)
The software verification and validation study results demonstrate that the ACL TOP Family 50 Series with updated nonanalytical features is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877).
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.
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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August 16, 2024
Instrumentation Laboratory (IL) Co. Sneh Pingle Regulatory Affairs Manager I 180 Hartwell Road Bedford, Massachusetts 01730
Re: K242127
Trade/Device Name: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: July 18, 2024 Received: July 19, 2024
Dear Sneh Pingle:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding
1
When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Min Wu-S
Min Wu. Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K242127
Device Name
ACL TOP Family 50 Series (ACL TOP 750 CTS; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 350 CTS; ACL TOP 350 CTS)
Indications for Use (Describe)
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory Company
180 Hartwell Road
Bedford, MA 01730-2443 (USA) |
| ------------------------- | ----------------------------------------------------------------------------------------- |
|---|
| Contact Person | Sneh Pingle
Regulatory Affairs Manager I
Phone: 781-674-3266
Fax: 781-861-4207
Email: spingle@werfen.com |
| ---------------- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
| Preparation Date | July 15, 2024 |
|---|---|
| ------------------ | --------------- |
| Device Trade Name | ACL TOP Family 50 Series Models: |
|---|---|
| ACL TOP 350 CTS ACL TOP 550 CTS ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS |
| Predicate Device | ACL TOP Family 50 Series | K150877 |
|---|---|---|
| ------------------ | -------------------------- | --------- |
| Regulatory Information | Regulation Section No. | 21 CFR 864.5400 |
|---|---|---|
| Regulation Description | Coagulation instrument | |
| Classification | Class II | |
| Product Code | GKP | |
| Panel | Hematology (81) |
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Device Description
The ACL TOP Family 50 Series 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 50 Series 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
The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).
Intended Use / Indications for Use
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
Special Conditions for Use Statement
· For prescription use only.
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Reason for Special 510(k) Submission
The new remote features introduced on the ACL TOP Family 50 Series are limited to adding permissionbased remote-control function for desktop sharing and remotely delivering software, OS updates (patches) and test parameter releases, utilizing security and privacy controls by design and installed by default. These features do not impact the analytical performance of the instrument and are already available on the ACL TOP Family 70 Series, FDA cleared under K231031.
The new remote features will be available to customers as an "optional add-on service" software tool called ProDx. This service software tool (ProDx) is being expanded beyond consistent monitoring, data gathering and capturing of quality control logs to now also include the following new remote features that are the subject of this Special 510(k):
- Added permission-based remote-control function for desktop sharing. ●
- Added functionality to remotely deliver software, OS updates (patches) and test parameter ● releases.
The above features are managed through cloud architecture for seamless and secure deployment; the same cloud architecture as already used on the ACL TOP Family 70 Series.
These new features will be available only for ACL TOP Family 50 Series instruments at Windows 10 (SW version 6.5.3). The features will not be available for ACL TOP Family 50 Series instruments at Windows 7.
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| Summary Comparison of Technological Characteristics (Predicate) | ||
|---|---|---|
| Item | Predicate Device (K150877) | Subject Device |
| Similarities | ||
| Trade Name | ACL TOP Family 50 Series | ACL TOP Family 50 Series |
| Model Trade Names | ACL TOP 350 CTS ACL TOP 550 CTS ACL TOP 750 CTS ACL TOP 750 ACL TOP 750 LAS | Same |
| Manufacturer | Instrumentation Laboratory Co. | Same |
| Indications for Use / | ||
| Intended Use | The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters. | Same | |
| Test Methodology | Coagulometric measurement Chromogenic measurement Immunological measurement | Same |
| Wavelengths | 405 nm 535 nm 671 nm | Same |
| Test Menu | Clotting Assays Chromogenic Assays Immunological Assays | Same |
| Test Parameters | Assay volumes, rinse and clean cycles, timing, optical parameters, data algorithms, material definition | Same |
| Summary Comparison of Technological Characteristics (Predicate) (Cont.) | ||
| Item | Predicate Device (K150877) | Subject Device |
| Similarities (Cont.) | ||
| Reagents, Controls and | ||
| Calibrators | Packaging, formulation, performance claims in labeling | Same |
| Fluidic Handling | Aspiration, dispense, mixing, rinse, clean, temperature control, bulk fluids | Same |
| Sample Handling | Cap piercing, onboard storage | Same |
| Onboard Reagent Storage | Stirring, temperature control | Same |
| Reaction and Detection | Optics, temperature control | Same |
| System Software | Hardware control, user interface except as noted in the Differences section below | Same |
| Quality Control | Automated QC | Same |
| Pre-Analytical HIL Check | Standard for all models: | |
| Third measurement wavelength @535 nm | ||
| and an additional emitter control channel | Same | |
| Tube Fill Height Check | Standard for all models | Same |
| Clog Detection | Standard for all models | Same |
| External Skins and Chassis | External Skins and Chassis | Same |
| On-market instrument | ||
| appearance | On-market instrument appearance | Same |
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| Differences | ||
|---|---|---|
| Item | Predicate Device (K150877) | Subject Device |
| Operating System | Windows 7 and Windows 10 | Same. |
| Software/ Cybersecurity | On-market instrument software and | |
| cybersecurity | Added permission-based remote-control | |
| function for desktop sharing and | ||
| remotely delivering software, OS | ||
| updates (patches) and test parameter | ||
| releases, utilizing security and privacy | ||
| controls by design and installed by | ||
| default. |
These new features will be available
only for ACL TOP Family 50 Series
instruments at Windows 10 (SW
version 6.5.3). The features will not be
available for ACL TOP Family 50
Series instruments at Windows 7.
Added new risk mitigation controls
(Example MS BitLocker, Digital
Signature, MS AppLocker) for enhanced
cybersecurity. |
Conclusion
The technological and functional characteristics of the ACL TOP Family 50 Series (subject device) as described herein are substantially equivalent to that of the ACL TOP Family 50 Series (predicate device). The software verification and validation study results demonstrate that the ACL TOP Family 50 Series with updated nonanalytical features is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877).