STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

K032482 · Stanbio Laboratory · GKR · Oct 24, 2003 · Hematology

Device Facts

• Record ID: K032482
• Device Name: STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
• Applicant: Stanbio Laboratory
• Product Code: GKR · Hematology
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5620
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The HemoPoint H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary whole blood of adults, infants, and children in a professional point-of-care setting. The microcuvettes part number 3010-100 is indicated for use in the Hemopoint® H2 Hemoglobin Measurement System and HemoCue® B-Hemoglobin Photometer.

Device Story

System consists of HemoPoint H2 photometer and disposable microcuvettes; used in professional point-of-care settings. Blood sample loaded into microcuvette via capillary action; cuvette inserted into photometer. Device utilizes modified azide methemoglobin (Vanzetti) method to measure color reaction; results displayed via LED readout. Includes time/data logging and storage capabilities. Provides rapid hemoglobin quantification to assist clinicians in diagnostic decision-making.

Clinical Evidence

Clinical studies across 4 sites compared the HemoPoint H2 to the NCCLS H15-A3 reference method and the HemoCue system. Correlation coefficients were >0.98 against the reference method and ≥0.97 against the HemoCue system. Precision testing (NCCLS EP5-A) showed within-run CVs ≤0.9% and total precision CVs ≤1.2% across high, low, and normal hemoglobin ranges.

Technological Characteristics

Photometric system using LEDs at 570 nm and 880 nm. Employs azide methemoglobin method for hemoglobin determination. Measures light transmission through undiluted blood in microcuvettes. Provides results in g/dL, g/L, or mol/L. Measurement time 30-60 seconds.

Indications for Use

Indicated for quantitative hemoglobin determination in arterial, venous, or 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.

Predicate Devices

• HemoCue B-Hemoglobin System

Submission Summary (Full Text)

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

A. 510(k) Number:
K032482

B. Analyte:
Hemoglobin

C. Type of Test:
Quantitative, photometric measurement of hemoglobin

D. Applicant:
Stanbio Laboratory

E. Proprietary and Established Names:
HemoPoint® H2 Hemoglobin Measurement System and HemoPoint® H2 Cuvettes

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

G. Intended Use:
1. Indication(s) for use:
The HemoPoint H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary whole blood of adults, infants, and children in a professional point-of-care setting. The microcuvettes part number 3010-100 is indicated for use in the Hemopoint® H2 Hemoglobin Measurement System and HemoCue® B-Hemoglobin Photometer.
2. Special condition for use statement(s):
The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
3. Special instrument Requirements:
N/A

H. Device Description:
The HemoPoint H2 Hemoglobin Measurement System is comprised of a HemoPoint H2 Hemoglobin Photometer and HemoPoint H2 disposable Cuvettes.

I. Substantial Equivalence Information:
1. Predicate device name(s):
HemoCue B-Hemoglobin System with microcuvette (K961312)
HemoCue Photometer (K832020)

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2. Predicate K number(s):
See above section.

3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate 1 | Predicate 2 |
| Intended Use | Quantitative determination of hemoglobin | Same | Same |
| Sample Requirements | Venous, arterial, or capillary blood | Same | Same |
| Methodology | Modified azide methemoglobin
Hct=estimation from hemoglobin | Hgb=Same
Hct=None | Hgb=Same
Hct=None |
| Differences | | | |
| Item | Device | Predicate 1 | Predicate 2 |
| Data Handling | Time/Data logging and data storage capability | Only with data management module | Only with data management module |

J. Standard/Guidance Document Referenced (if applicable):
1. H3-A4 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Fourth Edition, NCCLS.
2. H4-A4 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture; Approved Standard-Fourth Edition, NCCLS.
3. H11-A3 Procedures for the Collection of Arterial Blood Specimens; Approved Standard, NCCLS
4. H15-A3 Reference and Selected Procedures for the quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Edition, NCCLS.
5. EP9-A2 Method comparison and Bias Estimation Using Patient Samples; Approved Standard-Second Edition, NCCLS.
6. EP5-An Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, NCCLS.

K. Test Principle:
The device uses a modified azide methemoglobin method (Vanzetti) to measure hemoglobin.

A small amount of blood is loaded into the microcuvette via capillary action. The cuvette is then inserted into the HemoPoint H2 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:

| | Hemo Point H2 Cuvette
In HemoPoint Device | | HemoPoint H2 Cuvette
In HemoCue device | |
| --- | --- | --- | --- | --- |
| | With-in Run
(CV) | Total
(CV) | With-in Run
(CV) | Total
(CV) |
| Hemoglobin/Low
(10.7g/dL) | 0.9% | 1.1% | 0.6% | 0.8% |
| Hemoglobin/Normal
(12.9g/dL) | 0.7% | 1.1% | 0.8% | 1.0% |
| Hemoglobin/High
(17.3g/dL) | 0.6% | 1.2% | 0.6% | 0.9% |

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:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:

a. Method comparison with predicate device:
Comparison to NCCLS H15-A3 (y=0.023+1.006x, R=0.999, N=174 [duplicate measurements])

Comparison to predicate HemoCue (y=0.233+1.001x, R=0.998, N=286 [duplicate measurements])

Comparison of HemoPoint H2 cuvettes in Hemocue predicate (y=0.139+0.986x, R=0.999, N=286 [duplicate measurements])

b. Matrix comparison:
Capillary Samples. 4 sites (y=0.946x+0.3742x, R²=0.8256, N=275)
Venous Samples, 4 sites (y=1.0005x-0.2334x, R²=0.9962, N=286)
Arterial samples, 1 site (y=0.9868x-0.285, R²=0.997x, N=10)

3. Clinical studies:

a. Clinical sensitivity:
N/A

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b. Clinical specificity:
N/A

c. Other clinical supportive data (when a and b are not applicable):
N/A

4. Clinical cut-off:

5. Expected values/Reference range:
Expected values were based on the medical literature:

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:
Stanbio Laboratory has demonstrated that the HemoPoint H2 Hemoglobin
Measurement System is substantially equivalent to the HemoCue B-Hemoglobin
System.