STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

K081719 · Stanbio Laboratory · GKR · Jul 18, 2008 · Hematology

Device Facts

• Record ID: K081719
• Device Name: STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
• Applicant: Stanbio Laboratory
• Product Code: GKR · Hematology
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5620
• Device Class: Class 2

Indications for Use

The HemoPoint H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/L or 12.0 to 18.0 g/dL). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values and will not be reported. For In Vitro Diagnostic Use Only

Device Story

HemoPoint H2 Hemoglobin Measurement System consists of a photometer and single-use microcuvettes. Device analyzes undiluted blood samples via modified azide methemoglobin method (Vanzetti). Photometer uses LEDs at 570 nm (measurement) and 880 nm (turbidity compensation) to transmit light through the cuvette. Photodiode detects transmitted light; system calculates hemoglobin concentration using Lambert-Beers Law. Used in clinical settings for rapid hemoglobin assessment. Output displayed to healthcare provider for clinical decision-making regarding patient hemoglobin status. Benefits include rapid, point-of-care quantitative hemoglobin determination.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modification impact.

Technological Characteristics

Photometric system using LEDs at 570 nm and 880 nm. Employs modified azide methemoglobin chemical reaction in single-use microcuvettes. Measures light transmission to calculate hemoglobin via Lambert-Beers Law. Provides results in mol/L, g/dL, or g/L. Standalone device.

Indications for Use

Indicated for quantitative determination of hemoglobin in arterial, venous, or capillary blood. Hematocrit estimation provided only for normal hemoglobin ranges (12.0-18.0 g/dL); not for use in diagnosing anemia or abnormal states. Prescription use only.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K081719

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. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
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.
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.

The change was for the modification of the shape of the cuvette.

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 cuvette.

4. 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
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
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, 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.

5. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

(Reviewer's Signature)
(Date)

Revised: 3/27/98