Hemo Control (optional Add Pack Hemo Control DM)

K200909 · Ekf-Diagnostic GmbH · GKR · Jun 12, 2020 · Hematology

Device Facts

• Record ID: K200909
• Device Name: Hemo Control (optional Add Pack Hemo Control DM)
• Applicant: Ekf-Diagnostic GmbH
• Product Code: GKR · Hematology
• Decision Date: Jun 12, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5620
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood. The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood.

Device Story

Hemo Control is an automated hemoglobin measurement system; utilizes photometric measurement principle. Modification adds external barcode scanner hardware and LIS2-A2 transfer protocol software; enables data management functions including operator ID, cuvette lot, patient ID, and laboratory ID recording; allows result commenting and quality control test requests. Used in clinical settings; operated by healthcare professionals. Output provides hemoglobin concentration results; assists in anemia screening and monitoring. Device maintains fundamental scientific technology of previously cleared system.

Clinical Evidence

Bench testing only. Precision studies showed CVs ranging from 0.6% to 1.1% across low, normal, and high hemoglobin concentrations. Linearity range is 0-25.6 g/dL. Method comparison against NCCLS reference method (n=174) yielded r=0.0076 (y=1.0064x + 0.0234). Comparison against HemoCue system (n=286) yielded r=0.9962. Matrix comparison studies performed on capillary (n=275) and arterial (n=10) samples.

Technological Characteristics

Semi-automated spectrophotometric photometer. Uses reagent-filled microcuvettes for hem-azide methemoglobin reaction. Measures hemoglobin concentration and estimates hematocrit. Connectivity includes optional data management (Hemo Control DM). Calibrated against NCCLS reference method.

Indications for Use

Indicated for the quantitative determination of hemoglobin in capillary or venous human whole blood.

Regulatory Classification

Identification

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Predicate Devices

• Hemo_Control Hemoglobin Measurement System (K031898)

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

K200909

B Applicant

EKF-diagnostic GmbH

C Proprietary and Established Names

Hemo Control

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GKR | Class II | 21 CFR 864.5620 - Automated Hemoglobin System | HE - Hematology |

## 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: Hemo_Control Hemoglobin Measurement System, K031898.
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.
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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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This change was for adding hardware functionality through connecting an external barcode scanner and software functionality through addition of a LIS2-A2 transfer protocol and optional data management functions. The additional hardware and software functionality enable users to add comments to results, request a quality control test and scan and record the information including operator identification, cuvette lot information, patient identification and laboratory identification.

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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