← Product Code [GKZ](/productcode/GKZ) · K090013

# CHEMPAQ XBC ANALYZER (K090013)

_Chempaq A/S · GKZ · Apr 21, 2009 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K090013

## Device Facts

- **Applicant:** Chempaq A/S
- **Product Code:** [GKZ](/productcode/GKZ.md)
- **Decision Date:** Apr 21, 2009
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.5220
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Chempaq XBC Analyzer is intended for in vitro diagnostic use by trained laboratory professionals for the quantitative determination of hematology parameters in human whole blood samples.

## Device Story

Chempaq XBC Analyzer; hematology analyzer for quantitative blood analysis. Modification adds accessories: quality control cassette (QCC), liquid quality control material (LQC), linearity check materials, and barcode scanner. Software updated to support new accessories. Used by trained laboratory professionals in clinical settings. Device processes whole blood samples to provide hematology parameters. Modifications verified via design control activities, hazard analysis, and performance testing to ensure fundamental scientific technology remains unchanged from predicate.

## Clinical Evidence

No clinical data. Bench testing only. Testing included Quality Control Cassette (QCC) validation for electrical and photometric functions, Liquid Quality Controls (LQC), and linearity studies. Software verification and validation confirmed correct mode selection, error messaging for mismatches, and display accuracy.

## Technological Characteristics

Hematology analyzer; includes QCC, LQC, linearity materials, and barcode scanner. Software updated to support accessory integration. Fundamental scientific technology unchanged from predicate.

## 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

- Chempaq XBC Analyzer ([K090013](/device/K090013.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K090013

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. Chempaq XBC Analyzer, K050758, previously cleared device.
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).
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 the modification is for addition of accessories: quality control cassette, liquid quality control material, linearity checks, barcode code scanner, and software changes to support usage. In addition, modifications were made to labeling (users manual to support changes).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the addition of: Quality Control Cassette (QCC), Liquid Quality Controls (LQC), Linearity materials, and bar code scanner.

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 (Hazard Analysis, Appendix 1)
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 (Page 21)
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 (Page 29)
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. (Page 29)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

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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**Source:** [https://fda.innolitics.com/device/K090013](https://fda.innolitics.com/device/K090013)

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