(30 days)
Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in samples by: Subjecting the sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to let the reactants bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample.
This document is a 510(k) premarket notification for a software update to an existing medical device, the ACL AcuStar™. The submission qualifies as a "Special 510(k)" because the modification (updating the operating system from Windows XP to Windows 7) does not change the indications for use, operating principle, labeled performance claims, hardware, data reduction software, fluidic design, test parameters, calibration, quality control, consumables, or reagents. Therefore, the information provided focuses on demonstrating that the updated device is substantially equivalent to the predicate device and does not involve a new clinical study to establish acceptance criteria or device performance in the same way a de novo submission would.
Given the nature of this Special 510(k), the prompt's questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not directly applicable in the traditional sense for a new device evaluation. Instead, the "acceptance criteria" here relate to demonstrating that the change did not negatively impact the device's original validated performance.
Here's how the information aligns with the prompt's request, interpreted in the context of a Special 510(k) for a software update:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device itself because it's a software update to an already cleared device. Instead, the implicit acceptance criterion is that the device's performance remains unchanged despite the operating system upgrade.
The "reported device performance" in this context is that the updated device is substantially equivalent to the predicate device, meaning its performance characteristics relevant to its intended use have not been altered.
| Acceptance Criteria (Implicit for Special 510(k) Software Update) | Reported Device Performance (Conclusion) |
|---|---|
| No change in Indications for Use | Same |
| No change in Operating Principle | Same |
| No change to Labeled Performance Claims | Same (implies original performance claims are met) |
| No change to Hardware | Same |
| No change to Data Reduction Software | Same |
| No change to Fluidic Design | Same |
| No change to Test Parameters | Same |
| No change to Calibration | Same |
| No change to Quality Control | Same |
| No change to Consumables | Same |
| No change to Reagents | Same |
| Overall substantial equivalence to predicate device | The ACL AcuStar™ with software v3.0.1 running on Windows 7 is substantially equivalent to the cleared and currently marketed predicate device (K083518). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not detail a specific "test set" or its sample size in the context of clinical performance evaluation for this Special 510(k). The focus is on demonstrating that the software change itself does not affect the existing device's validated performance. For a software update of this nature, testing would typically involve verification and validation (V&V) activities against the original design specifications and potentially comparing outputs from the Windows XP and Windows 7 versions using a set of representative samples, but these details are not provided in this summary. There is no mention of country of origin or retrospective/prospective data for a new performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this Special 510(k). The regulatory submission for a software operating system update does not involve establishing new diagnostic ground truth with medical experts. The ground truth for the underlying assays was established during the initial clearance of the predicate device (K083518).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to this Special 510(k) as no new clinical test set requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The ACL AcuStar™ is an automated immunoassay analyzer, not a device involving human interpretation of images or data that would benefit from AI assistance in the way described for an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The ACL AcuStar™ is an automated system that performs tests in a standalone manner (without continuous human intervention for each test analysis beyond loading samples and reagents). The original predicate device's performance was established as a standalone automated system. The current submission simply states that the software update does not change the operating principle, performance claims, or data reduction software, implying the standalone performance remains identical to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the diagnostic assays performed by the ACL AcuStar™ would have been established during the original clearance of the predicate device (K083518), likely through comparison to reference methods, clinical diagnosis, or other accepted gold standards for in vitro diagnostic tests. This Special 510(k) does not provide details on the ground truth for the original assays, as it is assumed to be established with the predicate.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm that requires a training set in the common understanding of an "AI device." It's an automated immunoassay analyzer with a software operating system update.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 03, 2017
Instrumentation Laboratory Co. Ms. Nikita Malladi Senior Regulatory Affairs Specialist 180 Hartwell Road Bedford, MA 01730
Re: K170314
Trade/Device Name: ACL AcuStar™ Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in-vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: January 31, 2017 Received: February 01, 2017
Dear Ms. 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 requirements, including, but not limited to: registration and listing (21
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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Leonthena R. Carrington -S
Lea Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ACL AcuStar™
Indications for Use (Describe)
Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct 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
The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
| Submitter's Information | Instrumentation Laboratory (IL) Co. |
|---|---|
| 180 Hartwell Road | |
| Bedford, MA 01730, USA |
| Contact Person | Nikita Malladi, Senior Regulatory Affairs SpecialistPhone: 781-674-3245Fax: 781-861-4207Email: nmalladi@ilww.com |
|---|---|
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------ |
| Preparation Date | January 31, 2017 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | ACL AcuStar™ |
|---|---|
| ------------------- | -------------- |
| Regulatory Information | Classification: | Class II |
|---|---|---|
| Regulation No.: | 21 CFR 864.5425 | |
| Common Name: | System, Multipurpose For In Vitro CoagulationStudies | |
| Panel: | Hematology (81) | |
| Product Code: | JPA |
| Predicate Device | ACL AcuStar: K083518 |
|---|---|
| Indications for Use /Intended Use | The ACL AcuStar is an automated immunoassay analyzer designedspecifically for in vitro diagnostic use in a clinical laboratory. Theassay analysis is based on chemiluminescent technology. The |
system provides results for both direct measurements and
calculated parameters.
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| Device Description | The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in samples by: |
|---|---|
| Subjecting the sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to let the reactants bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample. |
| Description of Modification | This Special 510(k) is being submitted to update the operating system software from Windows XP to Windows 7 for the ACL AcuStar instrument. |
|---|---|
| ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- |
| Reason Submission Qualifies asSpecial 510(k) | The submission meets the criteria for a Special 510(k) based on thefollowing: |
|---|---|
| No change in indications for use or intended use No change in operating principle No change to labeled performance claims No change to hardware No change to data reduction software No change to fluidic design No change to test parameters No change to calibration No change to quality control No change to consumables No change to reagents |
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Comparison to Predicate Device (K083518):
Following is a description of the similarities and differences between the currently marketed ACL AcuStar Family (K083518) and ACL TOP Family with the Software 3.0.1 update:
| Item | Predicate Device(K083518) | Updated Device(with SW 3.0.1) |
|---|---|---|
| Trade Name | ACL AcuStar | Same |
| Indications for Use | ACL AcuStar is an automated immunoassay analyzerdesigned specifically for in vitro diagnostic use in aclinical laboratory. The assay analysis is based onchemiluminescent technology.The system provides results for both directmeasurements and calculated parameters. | Same |
| Physical Format | Single cartridge containing reagents | Same |
| Sample Type | Citrated Plasma or Serum (assay dependent) | Same |
| Dimensions | Height 54cm (21 ¼")Width 87cm (34 ¼")Depth 62cm (24 ½") | Same |
| Weight | 77.25 Kg (170.3 lbs) | Same |
| Methodology | Chemiluminescent technology | Same |
| Test Menu | Chemiluminescent immunoassays | Same |
| Software version | LR 10 | 3.0.1 |
| Operating System Software | Windows XP | Windows 7 |
Conclusion:
Based on the shared indications for use, operating principle, consumables, reagents, controls and calibrators, the ACL AcuStar with software v3.0.1 running on the Windows 7 operating system can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, ACL AcuStar.
§ 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.