(31 days)
No
The summary describes a standard automated laboratory analyzer for coagulation and fibrinolysis testing, focusing on established analytical methodologies and equivalence to a predicate device. There is no mention of AI, ML, or related concepts.
No.
This device is an in vitro diagnostic (IVD) random access analyzer used for coagulation and/or fibrinolysis testing, which helps in the assessment of thrombosis and/or hemostasis. It is not designed to directly treat or provide therapy to patients, but rather to provide diagnostic information to healthcare professionals.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "designed specifically for in vitro diagnostic use." It also specifies its role in "coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis," which are diagnostic purposes.
No
The device description clearly states it is a "bench top, fully automated, random access analyzer" and describes physical components like "two side-by-side test modules" and "optical measuring wavelengths." This indicates it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis."
N/A
Intended Use / Indications for Use
The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct measurements and calculated parameters.
Product codes (comma separated list FDA assigned to the subject device)
JPA
Device Description
The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series previously FDA cleared under K231031. This family member consists of two side-by-side test modules:
- Main Module (ACL TOP 550 CTS, K150877) the subject of this submission
- Chemiluminescent (CL) Module previously FDA cleared under K221359
The Main Module to the ACL TOP 970 CL 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 970 CL is an additional member of the ACL TOP Family 70 Series (K231031) and utilizes the same consumables, reagents, calibrators, and controls, and provides the same analytical methodology for routine and specialty assay result reporting as the predicate (ACL TOP Family 50 Series).
The ACL TOP 970 CL 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 a clinical 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 labeled performance data of the current menu of FDA-cleared (non-chemiluminescent) assays claimed for the ACL TOP Family 50 Series are applicable to the Main Module ACL TOP 970 CL. 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 an ACL TOP 970 CL instrument. These studies used samples 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 the Main Module side of ACL TOP 970 CL (subject device) to the ACL TOP 550 CTS (predicate device). The studies included clinical samples spanning each assay's analytical measuring range (AMR) to demonstrate the equivalent performance between the predicate and subject devices.
Sample sizes for method comparison were: HemosIL D-Dimer HS 500 (N=136), HemosIL Factor VIII deficient plasma (N=105), HemosIL RecombiPlasTin 2G (N=118), HemosIL RecombiPlasTin 2G (N=123), HemosIL Liquid Anti-Xa (N=139).
Main System Verification for HemosIL CL On-Market Reagents: A risk review of the Main System on the ACL TOP 970 CL was performed. Verification testing included Thermal Verification, Optical Stray Light Verification, and Environmental Verification, all of which confirmed that structural changes and new designs do not impact analytical results.
Conclusion: Based on the substantial equivalence comparison and the results of the verification testing that was conducted, it was concluded that the indications for use and technological characteristics of the Main Module on the ACL TOP 970 CL are substantially equivalent to the cleared and currently marketed predicate device, ACL TOP Family 50 Series (K150877), with shared performance claims for the FDA cleared on-market hemostasis (non-chemiluminescent) assay menu. The differences between the subject and predicate devices do not impact safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
Low Control: Mean 733, Within Run %CV 4.3, Total %CV 4.5
High Control: Mean 2664, Within Run %CV 2.5, Total %CV 2.8
Cut-off Plasma Pool: Mean 532, Within Run %CV 5.2, Total %CV 6.0
High Plasma Pool: Mean 2435, Within Run %CV 2.4, Total %CV 2.4
HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
Normal Control: Mean 93.3, Within Run %CV 3.7, Total %CV 4.6
Abnormal Control: Mean 26.5, Within Run %CV 3.7, Total %CV 6.5
Plasma Pool 1: Mean 41.5, Within Run %CV 6.3, Total %CV 7.3
Plasma Pool 2: Mean 5.8, Within Run %CV 4.4, Total %CV 5.4
HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds
Normal Control: Mean 11.5, Within Run %CV 0.5, Total %CV 1.2
Abnormal Pool: Mean 26.3, Within Run %CV 0.8, Total %CV 2.3
Low Abn Control: Mean 22.9, Within Run %CV 1.6, Total %CV 2.1
High Abn Control: Mean 38.7, Within Run %CV 1.1, Total %CV 2.6
HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL
Normal Control: Mean 387, Within Run %CV 0.9, Total %CV 1.4
Low Fibrinogen Control: Mean 178, Within Run %CV 6.1, Total %CV 6.3
Normal Pool: Mean 392, Within Run %CV 1.3, Total %CV 2.0
Abnormal Pool: Mean 109, Within Run %CV 1.8, Total %CV 2.4
HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL
UF Low Control: Mean 0.35, Within Run %CV 1.82, Total %CV 2.81
UF High Control: Mean 0.65, Within Run %CV 1.43, Total %CV 2.36
UF Pool: Mean 0.55, Within Run %CV 1.69, Total %CV 2.27
LMW High Control: Mean 1.57, Within Run %CV 1.18, Total %CV 2.15
LMW Low Control: Mean 0.64, Within Run %CV 2.55, Total %CV 2.81
LMW Pool: Mean 0.71, Within Run %CV 1.49, Total %CV 2.05
Method Comparison: (Slope, Intercept, r)
HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU: Slope 0.939, Intercept 27.0, r 0.996
HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity: Slope 1.045, Intercept 0.0, r 0.993
HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds: Slope 1.000, Intercept 0.25, r 0.998
HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL: Slope 0.991, Intercept 5.1, r 0.998
HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL: Slope 0.989, Intercept 0.015, r 0.997
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.
K231031, K221359, K172903, K034007, K070005, K213464
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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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December 29, 2023
Instrumentation Laboratory Nikita Malladi Regulatory Affairs Manager I 180 Hartwell Road Bedford, Massachusetts 01730
Re: K233790
Trade/Device Name: ACL TOP 970 CL Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: November 28, 2023 Received: November 28, 2023
Dear Nikita 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 (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 When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
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 QS 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 (QS) 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 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 W
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
2
Indications for Use
510(k) Number (if known) K233790
Device Name ACL TOP 970 CL
Indications for Use (Describe)
The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct 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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3
Image /page/3/Picture/0 description: The image shows the word "werfen" in a sans-serif font. The word is written in a dark blue color. The background is white, which makes the word stand out.
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 | Nikita Malladi
Regulatory Affairs Manager I
Phone: 781-353-1486
Fax: 781-861-4207
Email: nmalladi@werfen.com |
| ---------------- | -------------------------------------------------------------------------------------------------------------------------- |
|---|
| Preparation Date | December 29, 2023 |
|---|---|
| ------------------ | ------------------- |
| Device Trade Name | ACL TOP 970 CL |
|---|---|
| ------------------- | ---------------- |
| Predicate Device | ACL TOP Family 50 Series | K150877 |
|---|---|---|
| ------------------ | -------------------------- | --------- |
| Regulatory Information | Regulation Section No. | 21 CFR 864.5425 |
|---|---|---|
| Regulation Description | Multipurpose system for in vitro coagulation studies | |
| Classification | Class II | |
| Product Code | JPA | |
| Panel | Hematology (81) |
4
Device Description
The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series previously FDA cleared under K231031. This family member consists of two side-by-side test modules:
- . Main Module (ACL TOP 550 CTS, K150877) the subject of this submission
- Chemiluminescent (CL) Module previously FDA cleared under K221359 .
The Main Module to the ACL TOP 970 CL 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 970 CL is an additional member of the ACL TOP Family 70 Series (K231031) and utilizes the same consumables, reagents, calibrators, and controls, and provides the same analytical methodology for routine and specialty assay result reporting as the predicate (ACL TOP Family 50 Series).
The ACL TOP 970 CL 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 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct measurements and calculated parameters.
Reason for Special 510(k) Submission
This Special 510(k) is submitted for the following reasons:
- . To obtain FDA clearance for the Main Module (ACL TOP 550 CTS side) of the ACL TOP 970 CL instrument
- Following FDA clearance, to extend the current FDA cleared on-market hemostasis ● (non-chemiluminescent) assay menu for the ACL TOP Family 50 Series onto the ACL TOP 970 CL instrument through CLIA Categorization Requests
5
| Summary Comparison of Technological Characteristics (Predicate) | ||
|---|---|---|
| Item | Predicate Device (K150877) | Subject Device |
| Trade Name | ACL TOP Family 50 Series | ACL TOP 970 CL |
| (Main Module: ACL TOP 550 CTS) | ||
| Similarities | ||
| 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. | The ACL TOP 970 CL is a bench top, fully | |
| automated, random access analyzer | ||
| designed specifically for in vitro diagnostic | ||
| use by health care professionals in a clinical | ||
| laboratory for coagulation and/or | ||
| fibrinolysis testing in the assessment of | ||
| thrombosis and/or hemostasis. | ||
| The system provides results for both direct | ||
| measurements and calculated parameters. | ||
| 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 | |
| Reagents, Controls and | ||
| Calibrators | Packaging, formulation, performance claims in | |
| labeling | Same | |
| Summary Comparison of Technological Characteristics (Predicate) (Cont.) | ||
| Item | Predicate Device (K150877) | Subject Device |
| Trade Name | ACL TOP Family 50 Series | ACL TOP 970 CL |
| (Main Module; ACL TOP 550 CTS) | ||
| Similarities (Cont.) | ||
| 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 |
*Note: Chemiluminescent measurement on the ACL TOP 970 CL previously FDA cleared under K221359.
6
| Item | Predicate Device (K150877) | Subject Device |
|---|---|---|
| Differences | ||
| Chemiluminescence | ||
| Measurement | Not Applicable | Chemiluminescent (CL) Module |
| previously FDA cleared under K221359 |
7
Performance Summary
Analytical studies (specifically internal precision and method comparison) were performed on one lot of selected representative assays to establish that the labeled performance data of the current menu of FDAcleared (non-chemiluminescent) assays claimed for the ACL TOP Family 50 Series are applicable to the Main Module ACL TOP 970 CL. 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 an ACL TOP 970 CL instrument. These studies used samples with each material run for 20 days at two runs per day, 2 replicates per run (n=80).
Summary results are shown in the table below:
HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
| Material | Mean | Within Run %CV | Total %CV |
|---|---|---|---|
| Low Control | 733 | 4.3 | 4.5 |
| High Control | 2664 | 2.5 | 2.8 |
| Cut-off Plasma Pool | 532 | 5.2 | 6.0 |
| High Plasma Pool | 2435 | 2.4 | 2.4 |
HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
| Material | Mean | Within Run %CV | Total %CV |
|---|---|---|---|
| Normal Control | 93.3 | 3.7 | 4.6 |
| Abnormal Control | 26.5 | 3.7 | 6.5 |
| Plasma Pool 1 | 41.5 | 6.3 | 7.3 |
| Plasma Pool 2 | 5.8 | 4.4 | 5.4 |
| Precision | |||
| HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds | |||
| Material | Mean | Within Run %CV | Total %CV |
| Normal Control | 11.5 | 0.5 | 1.2 |
| Abnormal Pool | 26.3 | 0.8 | 2.3 |
| Low Abn Control | 22.9 | 1.6 | 2.1 |
| High Abn Control | 38.7 | 1.1 | 2.6 |
| HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL | |||
| Material | Mean | Within Run %CV | Total %CV |
| Normal Control | 387 | 0.9 | 1.4 |
| Low Fibrinogen Control | 178 | 6.1 | 6.3 |
| Normal Pool | 392 | 1.3 | 2.0 |
| Abnormal Pool | 109 | 1.8 | 2.4 |
| HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL | |||
| Material | Mean | Within Run %CV | Total %CV |
| UF Low Control | 0.35 | 1.82 | 2.81 |
| UF High Control | 0.65 | 1.43 | 2.36 |
| UF Pool | 0.55 | 1.69 | 2.27 |
| LMW High Control | 1.57 | 1.18 | 2.15 |
| LMW Low Control | 0.64 | 2.55 | 2.81 |
| LMW Pool | 0.71 | 1.49 | 2.05 |
8
9
Method Comparison
Method comparison studies were performed using one lot of the following selected representative assays to compare the performance on the Main Module side of ACL TOP 970 CL (subject device) to the ACL TOP 550 CTS (predicate device). The studies included clinical samples spanning each assay's analytical measuring range (AMR) to demonstrate the equivalent performance between the predicate and subject devices.
Summary results for are shown in the table below:
| HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU | |||||
|---|---|---|---|---|---|
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP 970 CL | 136 | 0.939 | 27.0 | 0.996 | ACL TOP 550 CTS |
| HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity | |||||
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP 970 CL | 105 | 1.045 | 0.0 | 0.993 | ACL TOP 550 CTS |
| HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds | |||||
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP 970 CL | 118 | 1.000 | 0.25 | 0.998 | ACL TOP 550 CTS |
| HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL | |||||
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP 970 CL | 123 | 0.991 | 5.1 | 0.998 | ACL TOP 550 CTS |
| HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL | |||||
| Subject System | N | Slope | Intercept | r | Predicate System |
| ACL TOP 970 CL | 139 | 0.989 | 0.015 | 0.997 | ACL TOP 550 CTS |
10
Main System Verification for HemosIL CL On-Market Reagents
A risk review of the Main System on the ACL TOP 970 CL, which has only minimal differences in hardware and software from the ACL TOP Family 50 Series to support the new Chemiluminescent (CL) System, was performed to identify the necessary verification testing. The following testing supports that there is no analytical impact on the existing HemosIL (non-chemiluminescent) test menu. Therefore, the current FDA-cleared assays can be extended onto the ACL TOP 970 CL without further testing.
| Thermal
| Verification | Verification testing was performed that confirmed the structural changes to the instrument (new skins, modified wall geometry) does not impact analytical results. |
|---|---|
| Optical Stray | |
| Light Verification | Verification testing was performed that a new back wall design does not impact analytical results. |
| Environmental | |
| Verification | Verification testing was performed that a change to the skin of the instrument and air intake modification does not impact analytical results. |
Conclusion
Based on the substantial equivalence comparison and the results of the verification testing that was conducted, it was concluded that the indications for use and technological characteristics of the Main Module on the ACL TOP 970 CL are substantially equivalent to the cleared and currently marketed predicate device, ACL TOP Family 50 Series (K150877), with shared performance claims for the FDA cleared on-market hemostasis (non-chemiluminescent) assay menu. The differences between the subject and predicate devices do not impact safety and effectiveness.