MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

K050338 · Akers Biosciences, Inc. · JIH · Mar 4, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050338
• Device Name: MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
• Applicant: Akers Biosciences, Inc.
• Product Code: JIH · Clinical Toxicology
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3560
• Device Class: Class 2

Indications for Use

The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).

Device Story

InstaRead™ Lithium System measures lithium concentration in whole blood samples (fingerstick or venous). Device provides quantitative lithium levels to assist clinicians in managing patients receiving lithium therapy for mental disturbances like bipolar disorder. System intended for professional use to monitor therapeutic drug levels, facilitating clinical decision-making regarding dosage adjustments to maintain therapeutic range and avoid toxicity.

Clinical Evidence

Field study performed to validate performance of modified reader; results demonstrated acceptance criteria met.

Technological Characteristics

Reader device; modified for permanent factory calibration; optimized for whole blood analysis; eliminates field re-calibration.

Indications for Use

Indicated for individuals undergoing lithium therapy for mental disturbances, including bipolar disorder (manic-depressive illness). Suitable for use with whole blood samples obtained via fingerstick or venous draw.

Regulatory Classification

Identification

A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K050338

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.) k031579
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 improved performance. Factory calibration has been modified so that the Reader now undergoes permanent factory calibration and no re-calibration is required in the field and the calibration has been optimized for whole blood.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and a field study was performed.
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.

Comments The risk analysis used was the Failure Mode Effects Analysis (FMEA). The acceptance criteria were met.

revised:8/1/03