← Product Code [GKR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR) · K031898

# EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM (K031898)

_Ekf Diagnostic GmbH · GKR · Sep 24, 2003 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K031898

## Device Facts

- **Applicant:** Ekf Diagnostic GmbH
- **Product Code:** [GKR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR.md)
- **Decision Date:** Sep 24, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5620
- **Device Class:** Class 2
- **Review Panel:** Hematology
- **Attributes:** Pediatric

## Indications for Use

The Hemo_Control is indicated for the quantitative determination of hemoglobin in arterial, venous, and capillary whole blood in adults, infants, and children in a professional point-of-care setting.

## Device Story

Hemo_Control system comprises photometer and single-use reagent-filled microcuvettes; used in professional point-of-care settings. Blood sample loaded into microcuvette via capillary action; inserted into photometer. Device utilizes azide methemoglobin method; measures color produced by chemical reaction. Results displayed via LED readout. Provides quantitative hemoglobin measurement to assist clinicians in hematological assessment.

## Clinical Evidence

No clinical data provided in the document; bench testing only.

## Technological Characteristics

Photometric measurement system using azide methemoglobin method. Includes photometer and single-use microcuvettes. Standards: EN 60601-1 (safety), EN 60601-1-2 (EMC), NCCLS H15-A3 (reference procedure). Features LED readout, time/date logging, and data storage. Calibrated against NCCLS reference method.

## Regulatory 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.

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K031898

B. Analyte:
Hemoglobin

C. Type of Test:
Quantitative, Photometric Measurement

D. Applicant:
EKF Diagnostic

E. Proprietary and Established Names:
Hemo_Control Hemoglobin Measurement System

F. Regulatory Information:
1. Regulation section:
21CFR 864.5620
2. Classification:
Class II
3. Product Code:
GKR
4. Panel:
Hematology (81)

G. Intended Use:
1. Indication(s) for use:
The Hemo_Control is indicated for the quantitative determination of hemoglobin in arterial, venous, and capillary whole blood in adults, infants, and children in a professional point-of-care setting.
2. Special condition for use statement(s):
3. Special instrument Requirements:

H. Device Description:
The Hemo_Control system consists of a photometer and individual single-use microcuvettes filled with reagents.

I. Substantial Equivalence Information:
1. Predicate device name(s):
HemoCue B-Hemoglobin System
Careside Hemoglobin
2. Predicate K number(s):
K973161
K001462
3. Comparison with predicate:

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|  Similarities  |   |   |   |
| --- | --- | --- | --- |
|  Item | Device | Predicate 1 | Predicate 2  |
|  Intended use | Quantitative determination of hemoglobin | Same | Same  |
|  Sample requirements | Venous, capillary, or arterial blood | Same | Same  |
|  Methodology | Hem-Azide methemoglobin
Hct-Estimation from hemoglobin | Hgb- Same
Hct-none | Hgb- none
Hct -same  |
|  Differences  |   |   |   |
|  Item | Device | Predicate 1 |   |
|  Data Handling Features | Time/Date Logging
Data Storage Capability | Some models
Some models |   |

J. Standard/Guidance Document Referenced (if applicable):
EN 60601-1 (03/96) Medical Electrical Equipment Part 1. General Requirements for Safety
EN 60601-1-2 (09/94) Medical Electrical Equipment Collateral Standard. Electromagnetic Compatibility Requirements & Tests
H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard- Third Edition, NCCLS
AAMI/ISO 14971 Medical Devices: Application of Risk Management to Medical Devices
93/42/EEC EU Law for Medical Products, device according to class IIa
HHS (FDA) 97-4224 In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions, January 1997
Guidance for FDA Staff – Regulating In Vitro Diagnostic Device (IVD) Studies, December 17, 1999
FDA Guidance Document-Reviewer Guidance for Premarket Notification
Submissions, Portions applicable to Electromagnetic compatibility, Nov. 1993
Guidance for Industry: Acceptance of Foreign Clinical Studies, March 2001
Guidance for FDA Staff: Regulation of In Vitro Diagnostic Device Studies, Dec 17, 1999

K. Test Principle:
The device uses an azide methemoglobin method to measure hemoglobin.

A small amount of blood is loaded into the microcuvette via capillary action. The cuvette is then inserted into the Hemo_Control photometer where the color produced by the chemical reaction in the cuvette is measured. Results are displayed by LED readout.

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L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

|   | With-in Run (CV) | Total (CV) | Single Observation 20 days (CV)  |
| --- | --- | --- | --- |
|  Hemoglobin/Low (107 g/L) | 0.8% | 1.0% | 0.9%  |
|  Hemoglobin/Normal (129 g/L) | 0.6% | 1.0% | 0.8%  |
|  Hemoglobin/High (173 g/L) | 0.6% | 1.1% | 1.0%  |

b. Linearity/assay reportable range: 0-25.6 g/dL

c. Traceability (controls, calibrators, or method): Device calibrated against NCCLS reference method

d. Detection limit:

e. Analytical specificity:

f. Assay cut-off:

2. Comparison studies:

a. Method comparison with predicate device:

Comparison to NCCLS Reference Method:  $y = 1.0064X + 0.0234$ ,  $r = 0.0076$ ,  $n = 174$

Comparison to predicate (HemoCue)  $y = 1.0005x - 0.2334$ ,  $r = 0.9962$ ,  $n = 286$

Comparison of Hemo_Control Cuvettes in HemoCue to predicate (HemoCue)  $y = .9855x + 0.139$ ,  $r = 0.998$ ,  $n = 286$

b. Matrix comparison:

Capillary Samples, 4 sites:

$y = 0.96x + 0.3742$ ,  $r = 0.8256$ ,  $n = 275$ ,

Arterial Samples, 1 site:

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y = 0.9868x - 0.0285, r = 0.998, n = 10

3. Clinical studies:
a. Clinical sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a and b is not applicable):

4. Clinical cut-off:

5. Expected values/Reference range:
Based on literature references

Women: 12.0 - 16.0 g/dl
Men: 13.0 - 17.5 g/dl
Children, depending on age: 9.0 -24 g/dl

M. Conclusion:
Performance data has demonstrated that this device is substantially equivalent to a legally marketed device.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K031898](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K031898)

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