CLINICAL LABORATORY ANALYZING SYSTEM

K041230 · Hemocue, Inc. · LFR · May 20, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041230
• Device Name: CLINICAL LABORATORY ANALYZING SYSTEM
• Applicant: Hemocue, Inc.
• Product Code: LFR · Clinical Chemistry
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201DM with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Glucose 201DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. The use of any other device in the HemoCue Glucose 201DM Analyzer except the HemoCue Glucose 201 Microcuvettes is neither supported not recommended by HemoCue, and could give erroneous results with serious clinical consequences. The HemoCue Glucose 201 Microcuvettes are for in vitro use only.

Device Story

System consists of HemoCue Glucose 201DM Analyzer and HemoCue Glucose 201 Microcuvettes; performs quantitative determination of glucose in whole blood. Input: whole blood sample in microcuvette. Operation: photometric analysis of blood glucose concentration; includes plasma conversion. Output: instant blood glucose concentration displayed to user. Used in clinical settings for diabetes management and neonatal monitoring. Healthcare providers use output to supplement clinical evidence for diagnosis and treatment decisions. Benefits: rapid, point-of-care glucose monitoring.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Modification adds data management system functionality. Fundamental scientific technology unchanged. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative determination of glucose in whole blood for diagnosis and treatment of patients with diabetes and monitoring of neonatal blood glucose levels.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K041230

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. This change was for the addition of a data management system on the device.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance protocols and acceptance criteria.
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
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.
6. 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.