HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM

K041234 · Hemocue, Inc. · GKR · Jun 10, 2004 · Hematology

Device Facts

• Record ID: K041234
• Device Name: HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
• Applicant: Hemocue, Inc.
• Product Code: GKR · Hematology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

The quantitative determination of hemoglobin in capillary, venous or arterial whole blood.

Device Story

HemoCue Hb 201 DM System is an automated hemoglobin analysis system. It utilizes a dedicated analyzer and specific microcuvettes to measure hemoglobin concentration in whole blood samples (capillary, venous, or arterial). The system functions as an analytical unit where the microcuvette acts as both a sample collection vessel and a reaction chamber. The analyzer performs optical measurements to quantify hemoglobin levels. It is intended for professional clinical use to provide rapid hemoglobin results, aiding in the assessment of patient hematological status. The system is designed to ensure accurate, point-of-care testing, allowing clinicians to make immediate decisions regarding patient care based on quantitative hemoglobin data.

Clinical Evidence

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

Technological Characteristics

Portable, handheld dual-wave photometer. Disposable microcuvettes with dry reagents. Optical path: 0.130 mm. Measurement principle: photometric determination of azidemethemoglobin. Calibration: factory-set with internal electronic self-test. Connectivity: docking station and PC software for data management.

Indications for Use

Indicated for quantitative determination of hemoglobin in capillary, venous, or arterial whole blood for point-of-care use.

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 INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K041234

B. Purpose for Submission:
Special 510(k) for software modification for enhanced data management features.

C. Manufacturer and Instrument Name:
HemoCue® Hb 201 DM System

D. Type of Test or Tests performed:
Hemoglobin

E. System Descriptions:

1. Device Description:
The HemoCue® Hb 201 DM System consists of a portable, factory calibrated, dual wave, hand held photometer, and disposable microcuvettes containing dry reagents. The analyzer and microcuvettes must be used together as a system.

2. Principles of Operation:
The HemoCue technique is based on an optical measuring microcuvette of a small volume and a short light path. The microcuvette cavity contains reagents deposited on its inner walls. The blood sample is drawn into the cavity by capillary action and is mixed spontaneously with the reagents. The microcuvette is then placed in the HemoCue Hb 201 DM analyzer in which the transmittance is assured and the hemoglobin level calculated. The distance between the walls of the optical window is 0.130 mm, which permits photometric determination of hemoglobin in undiluted blood. The reaction in the microcuvette is a modified azidemethemoglobin reaction. The erythrocyte membranes are disintegrated by sodium deoxycholate, releasing the hemoglobin. Sodium nitrite converts the hemoglobin iron from the ferrous to the ferric state to form methemoglobin which then combines with azide to form azidemethemoglobin. The predicate device was modified by making the analyzer dimensions smaller. This was achieved by conveying the light over a plastic bridge, instead of reflecting it off a beam splitting mirror. The light itself has not been changed. The shape of the microcuvette was changed so that it will fit only in the Hb 201 DM analyzer.

3. Modes of Operation:
Manual load

4. Specimen Identification:
Automatic numbering

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5. Specimen Sampling and Handling:
Capillary samples – microcuvettes are loaded by capillary action directly from fingerstick

Venous/Arterial-samples are collected into the appropriate anticoagulant (EDTA, heparin, or heparin/fluoride), mixed, and microcuvettes are loaded

6. Calibration:
Factory calibration

7. Quality Control:
The HemoCue® Hb 201 DM System has an internal electronic “self test” which automatically verifies the calibration of the instrument each time the analyzer is switched on and every second hour thereafter. Liquid quality control material is available for use on a daily basis.

8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☐ X ☐ or No ☐

F. Regulatory Information:

1. Regulation Section:
21 CFR 864.5620

2. Classification:
II

3. Product Code:
GKR

4. Panel:
81 Hematology

G. Intended Use:

1. Indication(s) for Use:
The quantitative determination of hemoglobin in capillary, venous or arterial whole blood.

2. Special Condition for use Statement(s):
Point-of-care

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:

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HemoCue® Hb 201 + System (K032203)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | The quantitative determination of hemoglobin in capillary, venous or arterial whole blood | same |
| Samples requirements | 10 μl blood | same |
| Methodology | Modified Vanzetti | same |
| Differences | | |
| Item | Device | Predicate |
| Software | Enhanced memory, docking station and PC software | 600 result memory |

I. Standard/Guidance Document Referenced (if applicable):

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:
b. Precision/Reproducibility:
c. Linearity:
d. Carryover:
e. Interfering Substances:

2. Other Supportive Instrument Performance Data Not Covered Above:

As required for a Special 510(k), the Sponsor has provided a risk analysis as well as a Declaration of Conformity with Design Controls indicating that development activities were conducted under appropriate design controls procedures, and the overall product specifications were met.

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K. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.