EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

K110393 · Ekf-Diagnostic GmbH · GKR · Mar 4, 2011 · Hematology

Device Facts

• Record ID: K110393
• Device Name: EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
• Applicant: Ekf-Diagnostic GmbH
• Product Code: GKR · Hematology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

The Hemo_Control Hemoglobin Measurement System is intended for the quantitative determination of hemoglobin in human capillary or venous whole blood.

Device Story

System consists of photometer and single-use microcuvettes containing dry reagents. User collects ~10 µL blood into microcuvette; inserts into photometer. Device uses modified azide methemoglobin method; LED light source and photodiode measure absorbance of undiluted blood. System calculates hemoglobin concentration via Lambert-Beers Law; displays result. Used in clinical settings for rapid hemoglobin assessment. Modification involves symmetrical sample inlet geometry to improve filling and reduce air bubbles. No changes to instrument hardware or software.

Clinical Evidence

Bench testing only. Precision evaluation (CLSI EP5-A) performed on 100 venous blood samples across low, normal, and high hemoglobin ranges. Correlation with CLSI H15-A3 reference method yielded R2=0.9955, range 7.6-24.2 g/dL.

Technological Characteristics

Photometric system using LED light source and photodiode. Single-use plastic microcuvettes with dry reagents. Measures undiluted blood via Lambert-Beers Law. No changes to instrument hardware or software. Symmetrical sample inlet geometry.

Indications for Use

Indicated for quantitative determination of hemoglobin in human capillary or venous whole blood for clinical 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.

Predicate Devices

• Hemo_Control Hemoglobin Measurement System (k031898)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k110393

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. Hemo_Control Hemoglobin Measurement System, k031898 previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for modification of the shape of the microcuvette.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance. The difference is in the shape of the microcuvette.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. (see pages 16-3, 16-4)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. (see pages 16-4, 16-5)
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, (see page 9-5) and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (see page 9-5)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure. (see page 6-1)

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.