HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

K192842 · Eurotrol B.V. · GGM · Nov 15, 2019 · Hematology

Device Facts

• Record ID: K192842
• Device Name: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
• Applicant: Eurotrol B.V.
• Product Code: GGM · Hematology
• Decision Date: Nov 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.

Device Story

HemoTrol Duo is an assayed quality control material used by healthcare professionals in point-of-care and laboratory settings to verify the performance of HemoCue Hb 301 and Hb 801 hemoglobin analyzers. The device consists of stroma-free bovine hemolysate containing hemoglobin in cyanmethemoglobin form, provided in three physiological levels (Low, Normal, High). Users dispense a drop of the control material onto a hydrophobic surface, then fill the analyzer's microcuvette according to manufacturer instructions. The analyzer measures absorbance via dual-wavelength spectrophotometry (506 and 880 nm). By comparing the analyzer's output against the assigned value range provided with the control, clinicians verify the accuracy and precision of the hemoglobin testing system. This process ensures the reliability of patient hemoglobin results, supporting clinical decision-making for conditions like anemia.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted across 3 sites using 3 batches per level on HemoCue Hb 301 and Hb 801 systems (5 replicates/day over 5 days). Hb 301 precision: CVs 2.2%–2.9%. Hb 801 precision: CVs 1.0%–1.7%. Stability studies confirmed 31-day open-vial stability at 30°C and 336-day closed-vial shelf life at 2-8°C.

Technological Characteristics

Assayed quality control material; stroma-free bovine hemolysate with cyanmethemoglobin and bioburden-controlling agents. Form factor: 1.0 ml reclosable plastic bottles with polypropylene caps. Principle: dual-wavelength spectrophotometry (506 and 880 nm). Storage: 2-8°C. No software or electronic components.

Indications for Use

Indicated for professional use in clinical and laboratory settings to verify performance of HemoCue Hb 301 and Hb 801 hemoglobin testing systems.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: K192842

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.