← Product Code [GKZ](/productcode/GKZ) · K042724

# MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER (K042724)

_Beckman Coulter, Inc. · GKZ · Oct 29, 2004 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K042724

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [GKZ](/productcode/GKZ.md)
- **Decision Date:** Oct 29, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.5220
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The COULTER® LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi- automated reticulocyte analysis.

## Device Story

The COULTER® LH 500 is an automated hematology analyzer used in clinical laboratories to perform complete blood counts (CBC), leukocyte differentials, and semi-automated reticulocyte analysis. It processes whole blood samples using the Coulter principle (electrical impedance) for cell counting/sizing and VCS technology (Volume, Conductivity, and light Scatter) for differential and reticulocyte analysis. The device identifies and classifies blood cells to separate normal patient samples from those requiring further diagnostic investigation. Operators are clinical laboratory personnel. The system output assists clinicians in diagnosing patient conditions by flagging samples that require manual review or definitive testing. The Version 2A software update enables the use of cyanide-free reagents (ISOTON 4 diluent/LYSE S 4 lytic agent) and includes corrections for previous software anomalies.

## Clinical Evidence

No clinical data provided. The submission relies on bench testing and performance verification to demonstrate that software modifications for cyanide-free reagent compatibility and anomaly resolution maintain the performance characteristics of the predicate device.

## Technological Characteristics

Hematology analyzer; software-based modification (Version 1A to 2A). Fundamental scientific technology remains consistent with predicate. Design controls applied per 21 CFR 820.30.

## Regulatory Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

## Predicate Devices

- Coulter LH 500 Hematology Analyzer ([K032000](/device/K032000.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

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K042724

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 (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Coulter® LH 500 Hematology Analyzer - #K032000

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 (labeling changes are permitted as long as they do not affect the intended use). This information is found on p. 19 and 26; and Section 3 of the submission.

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 upgraded software from Version 1A to Version 2A. Detailed information is found on pp. 17 – 19 and Section 3.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and technology. This information is found on pp. 17 – 19.

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. This information is found on pp. 20 – 22 and in Appendices A, B and D; and includes the following documents:

Development Project Plan, #178981

Document Change Management, #QSP-0007

Risk Analysis Report, PN 178903

Fault Tree Analysis (FTA) with Hazard Analysis, PN 178868

Failure Mode Effects Analysis (FMEA) PN 179153 and 2A Release FMEA, PN05

Product Design Validation

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. Data summaries, from performance testing listed on p. 22, are found in information supplied on 10/18/04.

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. This information is located on pp. 13 – 14.

{1}

2

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). These documents are found on pp. 8, 10 and 9, respectively.

The labeling for this 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 particular 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 (or their preamendment) device.

(Reviewer's Signature)  (Date)

Comments
Software documentation is found on pp. 22 – 24; and in Appendices C - F.

revised:8/1/03

---

**Source:** [https://fda-staging.innolitics.com/device/K042724](https://fda-staging.innolitics.com/device/K042724)

**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