(71 days)
No
The summary describes a standard automated coagulation analyzer and its analytical performance studies, with no mention of AI or ML technologies. The "pre-analytical features" described are rule-based alerts, not indicative of AI/ML.
No
This device is an in vitro diagnostic analyzer used for hemostasis testing, which provides diagnostic information rather than directly treating a condition.
Yes
This document explicitly states its intended use is for "in vitro diagnostic clinical use" in hemostasis testing, which directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "fully automated coagulation analyzer" and mentions hardware components like optical measuring wavelengths and pre-analytical features, indicating it is a physical instrument, not software only.
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 device is 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."
- Device Description: The description details how the device performs tests using biological samples (coagulometric, chromogenic, and immunological measurements), which is characteristic of an in vitro diagnostic device.
- Care Setting: The intended users are "health care professionals in the hemostasis laboratory," which is a typical setting for IVD use.
The information provided clearly indicates that this device is intended to be used outside of the body to examine specimens (like blood) to provide information for the diagnosis, treatment, or prevention of disease.
N/A
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.
Product codes
GKP
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.
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
health care professionals 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)
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 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).
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. Sample sizes were N=116 for HemosIL D-Dimer HS 500, N=104 for HemosIL Factor VIII deficient plasma, N=116 for HemosIL RecombiPlasTin 2G (Prothrombin Time), N=114 for HemosIL RecombiPlasTin 2G (Fibrinogen), and N=207 for HemosIL Liquid Anti-Xa. The results demonstrated high correlation (r values ranging from 0.998 to 1.000) and slopes close to 1, indicating equivalent performance to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
Low Control: Mean 676.9, Within Run %CV 4.5, Total %CV 4.8
High Control: Mean 2488.9, Within Run %CV 1.7, Total %CV 2.1
Cut-off Pool: Mean 569.9, Within Run %CV 6.4, Total %CV 6.5
High Pool: Mean 2486.6, Within Run %CV 2.0, Total %CV 2.0
HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
Normal Control: Mean 94.22, Within Run %CV 2.6, Total %CV 3.4
Abnormal Control: Mean 29.58, Within Run %CV 2.0, Total %CV 4.8
Plasma Pool 1: Mean 33.30, Within Run %CV 2.7, Total %CV 3.8
Plasma Pool 2: Mean 9.01, Within Run %CV 2.4, Total %CV 2.7
HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds
Normal Control (1): Mean 11.94, Within Run %CV 0.6, Total %CV 1.8
Normal Control (2): Mean 23.24, Within Run %CV 0.7, Total %CV 3.7
Low Abn Control: Mean 36.93, Within Run %CV 0.8, Total %CV 5.0
High Abn Control: Mean 38.10, Within Run %CV 0.9, Total %CV 4.0
HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL
Normal Control: Mean 339.1, Within Run %CV 0.9, Total %CV 3.9
Low Fibrinogen Control: Mean 140.7, Within Run %CV 6.4, Total %CV 8.1
Normal Pool: Mean 284.5, Within Run %CV 2.1, Total %CV 3.8
Abnormal Pool: Mean 136.9, Within Run %CV 4.3, Total %CV 5.0
HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL
UF Low Control: Mean 0.36, Within Run %CV 1.4, Total %CV 1.8
UF High Control: Mean 0.66, Within Run %CV 1.5, Total %CV 1.8
UF Pool: Mean 0.56, Within Run %CV 1.2, Total %CV 2.2
LMW High Control: Mean 1.50, Within Run %CV 1.9, Total %CV 2.2
LMW Low Control: Mean 0.58, Within Run %CV 2.2, Total %CV 2.6
LMW Pool: Mean 0.66, Within Run %CV 2.0, Total %CV 2.4
Method Comparison:
HemosIL D-Dimer HS 500 (K172903) – ng/mL FEU: N 116, Slope 1.022, Intercept 0.5575, r 0.998
HemosIL Factor VIII deficient plasma (K034007) – % Activity: N 104, Slope 1.006, Intercept -0.0587, r 0.998
HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time (Seconds): N 116, Slope 1.012, Intercept -0.0940, r 1.000
HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen (mg/dL): N 114, Slope 0.9756, Intercept -1.1220, r 0.999
HemosIL Liquid Anti-Xa (K213464) – Heparin (IU/mL): N 207, Slope 0.9804, Intercept -0.0145, r 0.999
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
1
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 (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
Enclosure
2
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) | |
|---|---|
| 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 | Carol Marble |
|---|---|
| Senior Director of Regulatory Affairs | |
| Phone: 781-861-4467 | |
| Fax: 781-861-4207 | |
| Email: cmarble@werfen.com |
| 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) |
4
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. ●
5
| 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 | |
| ACL TOP 550 CTS | ||
| ACL TOP 750 CTS | ||
| ACL TOP 750 | ||
| ACL TOP 750 LAS | ACL TOP 370 | |
| ACL TOP 570 | ||
| ACL TOP 770 | ||
| ACL TOP 770s | ||
| 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 / | ||
| 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: | |
| 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 |
| 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 | |
| cybersecurity | Updated Graphical User Interface (GUI) | |
| for aesthetics (e.g., higher resolution | ||
| icons) | ||
| Added the Study Mode internal function | ||
| to support laboratories in more efficiently | ||
| meeting their Quality System | ||
| requirements. The Study Mode provides | ||
| the interface for laboratories to organize | ||
| and execute their internal performance | ||
| studies, including collection of data for lot | ||
| comparison, instrument comparison, or | ||
| reference intervals. | ||
| Added permission-based remote-control | ||
| function for desktop sharing and remote | ||
| software delivery and upgrades, utilizing | ||
| security and privacy controls by design | ||
| and installed by default. |
6
7
8
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 |
9
| 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 |
10
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).