iQ200 Series

K252580 · Beckman Coulter, Inc. · LKM · Sep 10, 2025 · Hematology

Device Facts

• Record ID: K252580
• Device Name: iQ200 Series
• Applicant: Beckman Coulter, Inc.
• Product Code: LKM · Hematology
• Decision Date: Sep 10, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Indications for Use

The iQ200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel, and microscopic sediment analysis. Optionally, the iQ200 Analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

Device Story

iQ200 System is an automated urinalysis system and cell counter. Device modification involves removal of optional Lamina Cradle accessory. System operates in clinical laboratory settings to automate urine sample analysis. Fundamental scientific technology remains unchanged from previously cleared version. Healthcare providers use system outputs for diagnostic assessment of urine samples.

Clinical Evidence

No clinical data; bench testing not applicable as there were no changes to existing performance specifications.

Technological Characteristics

Automated urine microscopy; CCD video camera imaging; Auto-Particle Recognition (APR) software; specimen handling via autosampler; lamina layer flow cell; standalone or LIS-integrated connectivity.

Indications for Use

Indicated for automated urinalysis, including chemistry panel and microscopic sediment analysis, in patients requiring urine sediment evaluation. Provides quantitative/qualitative counts of cells, casts, crystals, and organisms. For use by trained technologists in clinical laboratory settings.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• iQ200 System (K252580)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K252580

B Applicant

Beckman Coulter, Inc

C Proprietary and Established Names

iQ200 System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LKM | Class II | 21 CFR 864.5200 - Automated Cell Counter | HE - Hematology |
| KQO | Class I | 21 CFR 862.2900 - Automated urinalysis system | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/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).
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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. This change was to remove the optional accessory Lamina Cradle.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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 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.

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