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Intended Use

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.

Device Description

The HemoCue® Hb 801 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.

The HemoCue® Hb 801 System consists of the following parts:

An analyzer supporting the following features: .
- O Photometric determination of hemoglobin
- Presentation of results on a display O
- O Wired and wireless communication (USB and Bluetooth)
Power supply by power adapter, chargeable or non- chargeable batteries ●
Single use microcuvettes (test consumable)
Labeling: ●
- O Operating Manual
- o Package Insert
- Quick reference Guide o
- o Labels

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 uL 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 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 801 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the HemoCue® Hb 801 System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document largely focuses on demonstrating equivalence to a predicate device and established reference methods, with direct explicit acceptance criteria only mentioned for linearity and anticoagulants. Performance is reported in terms of precision, linearity, and correlation with reference methods.

Test Category	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Precision (Whole Blood)	Not explicitly stated (implied to meet clinical needs and demonstrate consistency).	Multi-microcuvette lots study (Single site):

Hb 2.0-3.0 g/dL: Mean 2.43 g/dL, SD 0.05
Hb 6.0-7.0 g/dL: Mean 6.55 g/dL, SD 0.07
Hb 9.5-10.5 g/dL: Mean 9.96 g/dL, CV 0.68% (Repeatability), 0.71% (Within Lab), 1.11% (Reproducibility)
Hb 13.5-14.5 g/dL: Mean 14.07 g/dL, CV 0.71% (Repeatability), 0.82% (Within Lab), 1.16% (Reproducibility)
Hb 16.5-17.0 g/dL: Mean 16.87 g/dL, CV 0.60% (Repeatability), 0.73% (Within Lab), 0.95% (Reproducibility)
Hb 23.0-24.0 g/dL: Mean 23.39 g/dL, CV 0.67% (Repeatability), 0.77% (Within Lab), 0.97% (Reproducibility)

Overall precision (Multi-site):

Hb 2.0-3.0 g/dL: Mean 2.30 g/dL, SD 0.03 (R), 0.04 (WL), 0.05 (R)
Hb 6.0-7.0 g/dL: Mean 6.55 g/dL, SD 0.07 (R), 0.07 (WL), 0.08 (R)
Hb 9.5-10.5 g/dL: Mean 10.24 g/dL, CV 1.04% (R), 1.17% (WL), 1.63% (R)
Hb 13.5-14.5 g/dL: Mean 13.91 g/dL, CV 0.71% (R), 0.75% (WL), 1.00% (R)
Hb 16.5-17.0 g/dL: Mean 16.75 g/dL, CV 0.52% (R), 0.63% (WL), 0.66% (R)
Hb 23.0-24.0 g/dL: Mean 23.35 g/dL, CV 0.74% (R), 0.74% (WL), 0.89% (R) |
| Precision (Quality Control) | SD and CV calculated for repeatability, between-run, between-day, and within laboratory precision for each level were within the defined acceptance criteria. | Overall precision (Multi-site, multi-lots, operators, days): All reported SD and CV values (e.g., Low control: Mean 6.34 g/dL, SD 0.05 (R), 0.04 (WL), 0.06 (R)) were within the defined acceptance criteria. |
| Linearity | "fulfilled acceptance criteria for the non-linear error" (for range 1.0-25.6 g/dL). | System determined to be linear in the range 1.0-25.6 g/dL. |
| Detection Limit (LoB) | Not explicitly stated (calculated to be 0.26 g/dL). | LoB for the HemoCue® Hb 801 System was determined to be 0.26 g/dL. |
| Detection Limit (LoD) | Not explicitly stated (calculated to be 0.3 g/dL). | LoD for the HemoCue® Hb 801 System was determined to be 0.3 g/dL. |
| Quantification Limit (LoQ) | Total Error (TE) for each sample ≤ 0.5 g/dL. | LoQ for the HemoCue® Hb 801 System was determined to be 0.5 g/dL, meeting the TE goal. |
| Analytical Specificity | No significant interference at tested concentrations. | Most tested substances (Acetaminophen, Ascorbic acid, Creatinine, HbCO, HbO2, Hemolysis, Ibuprofen, MetHb, Platelets, Total protein, Salicylic acid, Simvastatin, Tetracycline, Triglycerides, Urea, Uric acid, Warfarin, Normal blood pH) showed no interference at respective concentrations.

Interference observed with:

Conjugated bilirubin (>23 mg/dL at 10 g/dL Hb)
Unconjugated bilirubin (>12 mg/dL at 10 g/dL Hb, >23 mg/dL at 20 g/dL Hb)
Intralipid (>214 mg/dL at 10 g/dL Hb, >483 mg/dL at 20 g/dL Hb)
Leucocytes (>260 x 10^9/L at 6.8 – 14.7 g/dL Hb)
(Note: "May give elevated results in higher substance concentrations".) |
| Anticoagulant Equivalence | Met the acceptance criteria regarding the correlation and bias between K2EDTA and Li-Heparin. | Both K2EDTA and Lithium Heparin samples fulfilled the acceptance criteria. |
| Capillary vs. Venous Sample | Met the defined acceptance criteria and showed equivalency. | Both venous and capillary samples were within the defined acceptance criteria and showed equivalency. |
| Method Comparison (Predicate)| Linear regression analysis demonstrated comparable performance. | Venous (N=264): Slope 1.00, Intercept -0.14, r 1.00 against predicate.
Capillary (N=233): Slope 1.07, Intercept -0.91, r 0.96 against predicate.

Pediatric samples (N=71):

HemoCue® Hb 801 vs ICSH: slope 0.95, r 0.99.
HemoCue® Hb 801 vs HemoCue® Hb 301 System: slope 0.97, r 0.99.

Both samples types were within defined acceptance criteria. |
| Reference Range Verification| Values fall within the expected pediatric and adult reference intervals. | Study results verified that the reference ranges data on the HemoCue® Hb 801 System for the subgroups fall within the defined reference ranges (e.g., Infant 9.4-14.1 g/dL, Adult Male 13.0-17.0 g/dL). |

2. Sample Size Used for the Test Set and Data Provenance

Precision (Whole Blood):
- Multi-microcuvette lots study: 6 hemoglobin levels, 5 operating days, 5 replicates per run, 3 microcuvette lots. Total 75 measurements per level. (Implied N = 6 levels * 75 measurements = 450).
- Multi-site study: 3 sites, 5 operating days, 5 replicates per run, 6 hemoglobin levels. Total 75 measurements per level. (Implied N = 6 levels * 75 measurements = 450).
- Provenance: Not explicitly stated, but clinical studies for method comparison mention primary care settings in the US and one European clinical laboratory. It is likely these precision studies were conducted in similar clinical laboratory environments. Retrospective/Prospective not specified, but likely prospective.
Precision (Quality Control Material):
- Sample size: Three sites, 20 operating days, 1 lot of control material (3 levels), duplicate runs twice daily. Total 240 measurements per level (80 per site). (Implied N = 3 levels * 240 measurements = 720).
- Provenance: Not explicitly stated, but likely clinical laboratory settings, potentially those mentioned for method comparison (US/Europe). Likely prospective.
Linearity:
- Sample size: 9 hemoglobin concentrations, 15 replicates per concentration (5 replicates/analyzer). (Implied N = 9 concentrations * 15 replicates = 135).
- Provenance: Clinical laboratory, likely prospective.
Detection Limit (LoB, LoD, LoQ):
- LoB: 4 individual plasma samples. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 2 replicates/analyzer per run. Total 72 replicates/microcuvette lot (Implied N = 2 lots * 72 replicates = 144).
- LoD: 4 K2EDTA whole blood samples from different subjects. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 2 replicates/analyzer per run. Total 72 replicates/microcuvette lot (Implied N = 2 lots * 72 replicates = 144).
- LoQ: 4 K2EDTA whole blood samples from different subjects. 3 analyzers, 2 microcuvette lots, 4 operating days. 1 sample analyzed each day, 3 runs per day, 3 replicates/analyzer per run. Total 108 replicates/microcuvette lot (Implied N = 2 lots * 108 replicates = 216).
- Provenance: Clinical laboratory, likely prospective.
Analytical Specificity:
- Sample size: K2EDTA whole blood samples with adjusted Hb levels. Number of samples/subjects not explicitly stated for each interferent, but tested at two Hb concentrations (10±0.5 and 20±1.0 g/dL).
- Provenance: Clinical laboratory, likely prospective.
Anticoagulant Equivalence:
- Sample size: 120 subjects provided both K2EDTA and Li-Heparin venous whole blood. Additional 11 subjects contributed samples to adjust Hb values.
- Provenance: Two sites, likely clinical settings, likely prospective.
Capillary vs. Venous Sample Equivalence:
- Sample size: 40 subjects for direct comparison, plus 212 subjects from the method comparison study (total 252).
- Provenance: Not explicitly stated, but likely related to the multi-site method comparison study in the US. Likely prospective.
Method Comparison (Predicate):
- Sample size:
  - US Study: 264 venous samples (28 contrived) and 233 capillary samples. Total 497.
  - European Clinical Lab: 71 pediatric samples.
- Provenance:
  - US Study: Five primary care settings in the US.
  - European Clinical Lab Study: One European clinical laboratory site.
- Retrospective/Prospective: Likely prospective.
Reference Range Verification:
- Sample size: Whole blood specimens collected. Number of individual samples not specified.
- Provenance: 5 point-of-care locations in the US. Likely prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No information provided regarding experts establishing ground truth for the test set. Most studies compare the device against a predicate device or the International Council for Standardization in Haematology (ICSH) reference method, which represents a gold standard, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. The studies described are analytical performance studies comparing the device to reference methods or a predicate, not studies involving human interpretation or adjudication of results. For the method comparison studies, duplicates were used for the predicate device, and triplicates for the ICSH reference method, implying a direct comparison of numerical results rather than an adjudication process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The studies are focused on the analytical performance of the device in measuring hemoglobin concentrations, primarily comparing it to a predicate device and a reference method. They do not evaluate human reader performance with or without AI assistance. The device is intended for non-laboratory personnel to use for direct numerical readings.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. All the analytical performance studies (precision, linearity, detection limits, analytical specificity, anticoagulant/sample type equivalence, and method comparison with predicate/ICSH) represent standalone performance of the HemoCue® Hb 801 System. The "system" includes the analyzer which uses an algorithm for translation into hemoglobin concentration. Users are described as "non-laboratory personnel" who obtain a direct reading from the device.

7. Type of Ground Truth Used

The ground truth varied depending on the study:
- Precision, Linearity, Detection Limits, Analytical Specificity: These studies establish the inherent performance characteristics of the device itself. The "ground truth" for the samples was their known or carefully prepared hemoglobin concentrations as measured by highly controlled laboratory methods.
- Anticoagulant and Capillary vs. Venous Equivalence: The "ground truth" was the comparison between the two sample types from the same subject.
- Method Comparison: The ground truth was established by:
  - The predicate device (HemoCue® Hb 301 System).
  - The hemiglobincyanide (HiCN) method, which is the International Council for Standardization in Haematology (ICSH) international reference method.
- Reference Range Verification: Comparison against published reference intervals from authoritative texts (Dacie and Lewis Practical Haematology, Pediatric Reference Intervals).

8. Sample Size for the Training Set

Not applicable/Not mentioned. This is an IVD device that measures a specific analyte using a spectrophotometric measuring principle with a pre-defined algorithm and factory calibration. There is no mention of a "training set" in the context of machine learning or AI algorithm development as typically understood in the context of image analysis or diagnostic prediction. The algorithm for translating light measurements into hemoglobin concentration is fundamental to the device's design, not something that appears to be "trained" on a large dataset in the sense of modern AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned. As noted above, typical "training sets" and their associated ground truth establishment methods (e.g., expert consensus labeling) are not relevant to the description of this device's development or validation. The device's fundamental measurement principle and algorithm are traceable to the HiCN method (ICSH), meaning its design and underlying calculations are based on established scientific principles for hemoglobin determination.

§ 864.5620 Automated hemoglobin system.