HemoCue Hb 301 System

K201217 · Hemocue AB · GKR · Aug 4, 2020 · Hematology

Device Facts

• Record ID: K201217
• Device Name: HemoCue Hb 301 System
• Applicant: Hemocue AB
• Product Code: GKR · Hematology
• Decision Date: Aug 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5620
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting. The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

Device Story

HemoCue Hb 301 System provides quantitative hemoglobin measurement; utilizes single-use polystyrene microcuvettes and photometer analyzer. Input: ~10 μL whole blood (venous, capillary, or arterial) drawn into microcuvette via capillary action. Operation: analyzer measures absorbance at 506 nm and 880 nm (isosbestic point) to compensate for turbidity; transmitted and scattered light processed via algorithm to calculate hemoglobin concentration. Used in primary care or blood donation settings by professional healthcare providers. Output: hemoglobin concentration displayed on analyzer. Results support clinical decision-making regarding anemia or hemoglobin status. Benefits: rapid, point-of-care testing without sample preparation or dilution.

Clinical Evidence

Bench testing and method comparison study. Study compared HemoCue Hb 301, HemoCue Hb 801, and reference ICSH HiCN method using 71 pediatric venous/capillary samples (range 6.4–22.8 g/dL). Results: Slope 0.982, Intercept 0.023, r=0.992. Secondary comparison between Hb 301 and Hb 801 showed Slope 1.015, Intercept -0.196, r=0.99. No clinical sensitivity/specificity studies required for this quantitative diagnostic device.

Technological Characteristics

Spectrophotometric analyzer; measures absorbance at Hb/HbO2 isosbestic point. Single-use microcuvette serves as pipette and measuring chamber. Power via adapter or 4 AA batteries. Factory calibrated; traceable to HiCN method (ICSH). Connectivity via serial port. Internal self-test for quality control.

Indications for Use

Indicated for quantitative hemoglobin determination in adults, adolescents, children, and infants ≥ 1 month old in primary care settings, and adults in blood donation 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® Hb 801 System (K181751)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K201217

B Applicant

HemoCue AB

C Proprietary and Established Names

HemoCue® Hb 301 System

D Regulatory Information

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

## II Submission/Device Overview:

A Purpose for Submission:

To expand the age of the target population from adults to $\geq 1$ month old when the device is used in primary care settings.

B Measurand:

Hemoglobin

C Type of Test:

Quantitative, photometric

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.

The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

C Special Conditions for Use Statement(s):
For Prescription Use Only

D Special Instrument Requirements:
None

IV Device/System Characteristics:

A Device Description:
The HemoCue Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using single-use microcuvettes and a photometer (analyzer). The HemoCue Hb 301 System consists of the following components:

- An analyzer supporting the following features:
- Photometric determination of hemoglobin
- Presentation of results on a display
- Power supply by power adapter or batteries
- Single use microcuvettes made of polystyrene plastic which do not contain reagents or active ingredients

B Principle of Operation:

K201217 - Page 2 of 7

{2}

The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 μL is drawn into the cavity in the microcuvette by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/HbO2 isosbestic point. The analyzer measures at two wavelengths (506 and 880 nm) in order to compensate for turbidity. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.

The HemoCue Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to International Council for Standardization in Hematology (ICSH) for the determination of the hemoglobin concentration in blood.

## C Instrument Description Information:

1. Instrument Name:
HemoCue® Hb 301 System

2. Specimen Identification:
There is no specimen identification function for the HemoCue Hb 301 system.

3. Specimen Sampling and Handling:
The HemoCue 301 microcuvette draws a small amount (approximately 10μL) of venous or capillary blood by capillary effect. The filled microcuvette is inserted into the microcuvette holder in the HemoCue Hb 301 analyzer.

4. Calibration:
The HemoCue Hb 301 System is factory calibrated and needs no further calibration.

5. Quality Control:
The HemoCue Hb 301 Analyzer has an internal quality control, a self-test. Every time the analyzer is turned on, it will automatically verify the system performance. This test is performed at regular intervals if the analyzer remains switched on.

If an external quality control is required by local or other regulations, commercially available controls recommended by HemoCue should be used.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

K201217 - Page 3 of 7

{3}

HemoCue® Hb 801 System

# B Predicate 510(k) Number(s):

K181751

# C Comparison with Predicate(s):

| Device & Predicate Device(s): | K201217 | K181751 |
| --- | --- | --- |
| Device Trade Name | HemoCue Hb 301 System | HemoCue Hb 801 System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The HemoCue Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings. The HemoCue Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue Hb 301 System is for professional in vitro diagnostic use only. | The HemoCue Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood (K2EDTA and Li-Heparin) in point-of-care settings. The HemoCue Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue® Hb 801 System is for professional in vitro diagnostic use only. |
| Patient population | Adults, adolescents, children, and infants above 1 month old | Same |
| Analyte | Hemoglobin | Same |
| Sample preparation (pre-treatment) | None | Same |
| Sample volume | 10 μL | Same |
| Measuring principle | Spectrophotometric | Same |
| Reagent | No active ingredients | Same |
| Calibration | The system is traceable to the hemiglobincyanide (HiCN) method, according to ICSH. The system is factory calibrated and needs no further calibration. | Same |
| Quality control | Internal self-test (verifying analyzer performance) | Same |

K201217 - Page 4 of 7

{4}

| General Device Characteristic Differences | | |
| --- | --- | --- |
| Sample type | Capillary, venous or arterial whole blood | Capillary or venous whole blood |
| Measuring range | 0-25.6 g/dL | 1-25.6g/dL |
| Connectivity | Serial port | • Wireless Bluetooth Low Energy (BLE)
• USB |
| Microcuvette insertion technique | Tray | “Slot in” |
| User interface | • Display
• Beeper
• One button | • Display
• Beeper
• Two buttons
• Status LED |

VI Standards/Guidance Documents Referenced:

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

The HemoCue Hb 301 System was previously cleared under K061047 for adults in the primary care setting and BK060048. The purpose of the current 510(k) submission is to expand the age of the target population from adults to ≥ 1 month old. The previously submitted analytical performance studies are documented in K061047 and BK060048.

B Comparison Studies:

1. Method Comparison with Predicate Device:

The sponsor conducted a method comparison study in which 71 venous and capillary pediatric samples were analyzed on the HemoCue Hb 301 system, HemoCue Hb 801 system, and reference method ICSH. The reference hemiglobincyanide (HiCN) method used by HemoCue AB is a manual method set up according to CLSI H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition.

Deming regression analyses were performed to estimate the parameters of the regression model (i.e. slope, intercept, 95% confidence intervals). The results of this comparison study are provided in the table below.

K201217 - Page 5 of 7

{5}

| Parameter | N | Sample Range Tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Hemoglobin (g/dL) | 71 | 6.4 g/dL – 22.8 g/dL | 0.982 | 0.023 | 0.992 |

2. Matrix Comparison:

Refer to K061047

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable

2. Clinical Specificity:

Not applicable

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable

D Clinical Cut-Off:

Not applicable

E Expected Values/Reference Range:

Refer to K061047

F Other Supportive Instrument Performance Characteristics Data:

A secondary comparison study was performed with the HemoCue Hb 301 system and the HemoCue Hb 801 system. This study involved the same pediatric samples as those described in Section B.1 above. Deming regression analyses were performed to estimate the parameters of the regression model (i.e. slope, intercept, 95% confidence intervals). The results of this comparison study are provided in the table below.

| Parameter | N | Sample Range Tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Hemoglobin (g/dL) | 71 | 6.4 g/dL – 22.8 g/dL | 1.015 | -0.196 | 0.99 |

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

K201217 - Page 6 of 7

{6}

IX Conclusion:

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

K201217 - Page 7 of 7