STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM

K090093 · Stanbio Laboratory · GKR · Jun 10, 2009 · Hematology

Device Facts

• Record ID: K090093
• Device Name: STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
• Applicant: Stanbio Laboratory
• Product Code: GKR · Hematology
• Decision Date: Jun 10, 2009
• 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. The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information. Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Story

HemoPoint H2 Hemoglobin Measurement System; modified to include H2 DataLink configuration software. System measures hemoglobin; H2 DataLink enables display, storage, and transmission of results to computer. Used in clinical settings; operated by healthcare professionals. Modification involves data management system; fundamental scientific technology remains unchanged.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to assess impact of data management system modification. Results met predetermined acceptance criteria.

Technological Characteristics

Photometric system using LEDs at 570 nm and 880 nm. Azide methemoglobin chemical reaction. Single-use microcuvettes. Measurement range 0-25.6 g/dL. Accuracy ± 0.3 g/dL at ~14 g/dL. Data management software for result storage. Class II 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.

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

• HemoPoint®, H2 Hemoglobin Measurement System (K081719)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K090093

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. HemoPoint®, H2 Hemoglobin Measurement System, K081719 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 the modification of the data management system.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the addition of H2 DataLink, configuration software for HemoPoint H2 DM used to display and store results as well as transmit data to a computer.
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 (Hazard Analysis, following revised User's Manual in front.)
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 (Section 5, pages 80-175)
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 (Section 6, page 2)
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. Section 6, page 2)
iii) A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

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.