Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

K053110 · I-Stat Corporation · JGS · Jan 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053110
• Device Name: Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
• Applicant: I-Stat Corporation
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood.

Device Story

i-STAT CHEM8+ Cartridges; single-use, in vitro diagnostic test cartridges for point-of-care blood analysis. Device combines multiple electrochemical sensors into a single cartridge to measure Sodium, Potassium, Chloride, Urea Nitrogen, Glucose, Hematocrit, Calcium, Creatinine, and Total CO2; calculates Anion Gap and Hemoglobin. Used by healthcare professionals in clinical settings to provide rapid diagnostic results from whole blood samples. Modification involves integrating electrode configurations from previously cleared i-STAT cartridges into a single platform. Output displayed on i-STAT analyzer; assists clinicians in rapid metabolic and electrolyte assessment.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to electrode configuration did not impact device performance or intended use.

Technological Characteristics

Single-use cartridge for use with i-STAT 1 Analyzer. Employs electrochemical sensing technology consistent with existing i-STAT cartridges. Factory-calibrated. Software-controlled analysis cycle. No specific materials or ASTM standards provided.

Indications for Use

Indicated for use by medical professionals to monitor kidney function, electrolyte balance, and blood sugar levels. Used to assess conditions including hypertension and hypokalemia in patients requiring quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

• i-STAT System (K894914)
• i-STAT System (K934642)
• i-STAT System (K936081)
• i-STAT System (K940918)
• i-STAT System (K973292)

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 K053110

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.) k894914, k894914, k934642, k936081, k940918, k973292
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 ___i-STAT CHEM8+ Cartridges, new cartridge was created to combine the electrodes from previous cartridges for detecting Sodium, Potassium, Chloride, Urea Nitrogen, Glucose, Hematocrit, Calcium, Creatinine, Total CO2, Anion Gap, Hemoglobin.

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