ACL TOP Family 70 Series

K231031 · Instrumentation Laboratory Company · GKP · Jun 21, 2023 · Hematology

Device Facts

• Record ID: K231031
• Device Name: ACL TOP Family 70 Series
• Applicant: Instrumentation Laboratory Company
• Product Code: GKP · Hematology
• Decision Date: Jun 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Intended Use

The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals 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.

Device Story

Bench-top, fully automated, random access coagulation analyzers; used in hemostasis laboratories by healthcare professionals. Inputs: clinical samples (plasma). Principle: optical measurement (turbidimetric, chromogenic, immunological) at 405, 535, and 671 nm. Outputs: quantitative results for coagulation/fibrinolysis assays and calculated parameters. Features: pre-analytical HIL (Hemoglobin, Icteric, Lipemia) interference detection, underfilled tube detection, and clog detection. Updated features include 22-inch touchscreen, aesthetic GUI updates, 'Study Mode' for internal performance studies, and permission-based remote-control for desktop sharing/software updates. Clinical utility: aids in thrombosis and hemostasis assessment; provides standardized, automated testing to support clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (n=80 per model) evaluated D-Dimer, Factor VIII, PT, Fibrinogen, and Heparin assays, meeting all acceptance criteria for repeatability and within-laboratory precision. Method comparison studies (n=104-260 samples) against the predicate (ACL TOP 750 CTS) demonstrated high correlation (r > 0.99) across all assays, confirming equivalent performance.

Technological Characteristics

Benchtop, fully automated, random-access coagulation analyzer. Optical detection (405, 535, 671 nm). Barcode-based sample/reagent identification. Cap-piercing sample handling. Onboard refrigerated reagent storage with stirring. 22-inch color touchscreen interface. Connectivity includes remote-control functionality for desktop sharing and software updates. Compliant with IEC 61010-1, 61010-2-101, 61010-2-010, 61326-1, 61326-2-6, and 60601-1-2 standards.

Indications for Use

Indicated for use by healthcare professionals in hemostasis laboratories for coagulation and/or fibrinolysis testing to assess thrombosis and/or hemostasis. Prescription use only.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*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.

Predicate Devices

• ACL Top Family 50 Series: ACL Top 350 CTS; ACL Top 550 CTS; ACL Top 750; ACL Top 750 CTS; ACL Top 750 LAS (K150877)

Submission Summary (Full Text)

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June 21, 2023

Instrumentation Laboratory Company Carol Marble Senior Director of Regulatory Affairs 180 Hartwell Road Bedford, Massachusetts 01730

Re: K231031

Trade/Device Name: ACL TOP Family 70 Series Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: April 10, 2023 Received: April 11, 2023

Dear Carol 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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] 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

Enclosure

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# Indications for Use

510(k) Number (if known) K231031

Device Name ACL TOP Family 70 Series

#### Indications for Use (Describe)

The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:rgb(0,0,0)" width="12"></rect> <path d="M2 2 L10 10 M10 2 L2 10" stroke="rgb(0,0,0)" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span> 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<br>180 Hartwell Road<br>Bedford, MA 01730-2443 (USA) |
|-------------------------|-----------------------------------------------------------------------------------------|
|-------------------------|-----------------------------------------------------------------------------------------|

| Contact Person | Carol Marble |
|----------------|---------------------------------------|
| | Senior Director of Regulatory Affairs |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

| Preparation Date | June 15, 2023 |
|------------------|---------------|
|------------------|---------------|

| Device Trade Names | ACL TOP Family 70 Series models: |
|--------------------|----------------------------------|
| | • ACL TOP 370 |
| | • ACL TOP 570 |
| | • ACL TOP 770 |
| | • ACL TOP 770s |
| | • ACL TOP 770 LAS |

| Predicate Device | ACL TOP Family 50 Series | K150877 |
|------------------|--------------------------|---------|
|------------------|--------------------------|---------|

| Regulatory Information | | | | |
|------------------------|------------------------|----------------|--------------|-----------------|
| Regulation No. | Regulation Description | Classification | Product Code | Panel |
| 21 CFR 864.5400 | Coagulation Instrument | II | GKP | Hematology (81) |

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#### Device Description

The ACL TOP Family 70 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 50 Series.

The ACL TOP Family 70 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family 50 Series:

- . Coagulometric (Turbidimetric) Measurements
- Chromogenic (Absorbance) Measurements .
- . Immunological Measurements

The ACL TOP Family 70 Series also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features 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.

## Intended Use / Indications for Use

The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals 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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| Summary Comparison of Technological Characteristics (Predicate) | | |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate Device (K150877) | Subject Device |
| Similarities | | |
| Trade Names | ACL TOP Family 50 Series | ACL TOP Family 70 Series |
| Model Trade Names | ACL TOP 350 CTS<br>ACL TOP 550 CTS<br>ACL TOP 750 CTS<br>ACL TOP 750<br>ACL TOP 750 LAS | ACL TOP 370<br>ACL TOP 570<br>ACL TOP 770<br>ACL TOP 770s<br>ACL TOP 770 LAS |
| Manufacturer | Instrumentation Laboratory Co. | Same |
| Classification | Class II | Same |
| Review Panel | Hematology (81) | Same |
| Regulation Description | Instrument, Coagulation, Automated | Same |
| Product Code | GKP | Same |
| Regulation Section | 21 CFR 864.5400 | Same |
| Indications for Use /<br>Intended Use | The ACL TOP Family 50 Series (ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750 LAS) 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 provides results for both direct hemostasis measurements and calculated parameters. | The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals 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. |
| Test Methodology | Coagulometric measurement Chromogenic measurement Immunological measurement | Same |
| Wavelengths | 405 nm 535 nm 671 nm | Same |
| Summary Comparison of Technological Characteristics (Predicate) (Cont.) | | |
| Item | Predicate Device (K150877) | Subject Device |
| | Similarities (Cont.) | |
| 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 |
| 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:<br>Third measurement wavelength @535 nm<br>and an additional emitter control channel | Same |
| Tube Fill Height Check | Standard for all models | Same |
| Clog Detection | Standard for all models | Same |
| Summary Comparison of Technological Characteristics (Predicate) (Cont.) | | |
| Item | Predicate Device (K150877) | Subject Device |
| Differences | | |
| External Skins and Chassis | On-market instrument appearance | Updated instrument appearance |
| Control Module Monitor | 17-inch color touchscreen monitor | 22-inch color touchscreen monitor |
| Software / Cybersecurity | On-market instrument software and<br>cybersecurity | Updated Graphical User Interface (GUI)<br>for aesthetics (e.g., higher resolution<br>icons) |
| | | Added the Study Mode internal function<br>to support laboratories in more efficiently<br>meeting their Quality System<br>requirements. The Study Mode provides<br>the interface for laboratories to organize<br>and execute their internal performance<br>studies, including collection of data for lot<br>comparison, instrument comparison, or<br>reference intervals. |
| | | Added permission-based remote-control<br>function for desktop sharing and remote<br>software delivery and upgrades, utilizing<br>security and privacy controls by design<br>and installed by default. |

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#### Performance Summary

Analytical studies (specifically internal precision and method comparison) were performed on one lot of selected representative assays to establish that the updates introduced with the ACL TOP Family 70 Series do not impact the labeled performance data of the current menu of FDA-cleared assays claimed for the ACL TOP Family 50 Series. These studies followed recognized guidelines:

- CLSI EP05-A3
- . CLSI EP09c. 3rd Ed

All analytical studies were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met and results equivalent to the predicate device.

#### Precision

Precision studies were performed using one lot of the following selected representative assays tested on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). These studies used samples and controls with each material run for 20 days at two runs per day, 2 replicates per run (n=80).

Summary results for a representative ACL TOP Family 70 Series model are shown in the table below:

| Material | Mean | Within Run %CV | Total %CV |
|--------------|--------|----------------|-----------|
| Low Control | 676.9 | 4.5 | 4.8 |
| High Control | 2488.9 | 1.7 | 2.1 |
| Cut-off Pool | 569.9 | 6.4 | 6.5 |
| High Pool | 2486.6 | 2.0 | 2.0 |

## HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU

HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity

| Material | Mean | Within Run %CV | Total %CV |
|------------------|-------|----------------|-----------|
| Normal Control | 94.22 | 2.6 | 3.4 |
| Abnormal Control | 29.58 | 2.0 | 4.8 |
| Plasma Pool 1 | 33.30 | 2.7 | 3.8 |
| Plasma Pool 2 | 9.01 | 2.4 | 2.7 |

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| Precision | | | |
|----------------------------------------------------------------|-------|----------------|-----------|
| HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds | | | |
| Material | Mean | Within Run %CV | Total %CV |
| Normal Control | 11.94 | 0.6 | 1.8 |
| Normal Control | 23.24 | 0.7 | 3.7 |
| Low Abn Control | 36.93 | 0.8 | 5.0 |
| High Abn Control | 38.10 | 0.9 | 4.0 |
| HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL | | | |
| Material | Mean | Within Run %CV | Total %CV |
| Normal Control | 339.1 | 0.9 | 3.9 |
| Low Fibrinogen Control | 140.7 | 6.4 | 8.1 |
| Normal Pool | 284.5 | 2.1 | 3.8 |
| Abnormal Pool | 136.9 | 4.3 | 5.0 |
| HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL | | | |
| Material | Mean | Within Run %CV | Total %CV |
| UF Low Control | 0.36 | 1.4 | 1.8 |
| UF High Control | 0.66 | 1.5 | 1.8 |
| UF Pool | 0.56 | 1.2 | 2.2 |
| LMW High Control | 1.50 | 1.9 | 2.2 |
| LMW Low Control | 0.58 | 2.2 | 2.6 |
| LMW Pool | 0.66 | 2.0 | 2.4 |

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#### Method Comparison

Method comparison studies were performed using one lot of the following selected representative assays to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770 or ACL TOP 770 LAS) to a representative ACL TOP Family 50 Series model (ACL TOP 750 CTS). The studies included clinical samples spanning each assay's analytical measuring range (AMR) to demonstrate the equivalent performance between the subject and predicate devices.

Summary results for a representative ACL TOP Family 70 Series model are shown in the table below:

| HemosIL D-Dimer HS 500 (K172903) – ng/mL FEU | | | | | |
|------------------------------------------------------------------|-----|--------|-----------|-------|--------------------------|
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP Family 70 Series | 116 | 1.022 | 0.5575 | 0.998 | ACL TOP Family 50 Series |
| HemosIL Factor VIII deficient plasma (K034007) – % Activity | | | | | |
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP Family 70 Series | 104 | 1.006 | -0.0587 | 0.998 | ACL TOP Family 50 Series |
| HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time (Seconds) | | | | | |
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP Family 70 Series | 116 | 1.012 | -0.0940 | 1.000 | ACL TOP Family 50 Series |
| HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen (mg/dL) | | | | | |
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP Family 70 Series | 114 | 0.9756 | -1.1220 | 0.999 | ACL TOP Family 50 Series |
| HemosIL Liquid Anti-Xa (K213464) – Heparin (IU/mL) | | | | | |
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP Family 70 Series | 207 | 0.9804 | -0.0145 | 0.999 | ACL TOP Family 50 Series |

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#### Conclusion

The technological and functional characteristics of the ACL TOP Family 70 Series (subject device) as described herein are substantially equivalent to that of the ACL TOP Family 50 Series (predicate device). The analytical study results demonstrate that the ACL TOP Family 70 Series with updated non-analytical features is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877).