EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

K031898 · Ekf Diagnostic GmbH · GKR · Sep 24, 2003 · Hematology

Device Facts

• Record ID: K031898
• Device Name: EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
• Applicant: Ekf Diagnostic GmbH
• Product Code: GKR · Hematology
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5620
• Device Class: Class 2
• 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.

Indications for Use

Indicated for quantitative hemoglobin determination in arterial, venous, and capillary whole blood for adults, infants, and children in professional point-of-care settings.

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.

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.