← Product Code [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA) · K170314

# ACL AcuStar (K170314)

_Instrumentation Laboratory CO · JPA · Mar 3, 2017 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K170314

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA.md)
- **Decision Date:** Mar 3, 2017
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

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.

## Device Story

ACL AcuStar™ instrument; automated diagnostic system. Modification involves OS update from Windows XP to Windows 7. Device maintains fundamental scientific technology, fluidic design, and hardware of predicate. Used in clinical laboratory settings for diagnostic testing. Software update managed via design controls and risk analysis per ISO 14971 and AAMI TIR 45 to ensure safety, effectiveness, and cybersecurity integrity. Output remains consistent with previously cleared device; no impact on clinical decision-making or patient outcomes.

## Clinical Evidence

No clinical data provided. The submission relies on bench testing to verify the software update (OS migration) does not impact device performance or safety.

## Technological Characteristics

Instrument-based diagnostic system. Modification: OS migration from Windows XP to Windows 7. Software development follows IEC 62304 and AAMI TIR 45. Cybersecurity controls integrated into ALBA Host Software. Fundamental scientific technology, fluidic design, and hardware unchanged from predicate.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- ACL AcuStar™ ([K083518](/device/K083518.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K170314

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: ACL AcuStar™, K083518
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for an update of the operating system software from Windows XP to Windows 7 for the ACL AcuStar™ instrument.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, operating principle, hardware, data reduction software, fluidic design and test parameters.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The Risk Analysis for the proposed change was conducted in accordance with ISO 14971 and SLT Risk Management Procedures. The applied risk analysis methods follow guidelines defined in AAMI TIR 45 (Guidance on the use of agile practices in the development of medical device software) to conciliate agile methods and techniques with 21 CFR 820.30, ISO13485 and IEC 62304 requirements. The scope of the risk analysis covers patient, operator, environmental safety and the data protection from damage to its confidentiality, integrity or availability. Cybersecurity has been included in the ALBA Host Software risk analysis. It was concluded that the proposed change does not pose any additional risks and there is no impact on the safety or effectiveness of the product.

The labeling for the modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K170314](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K170314)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com