AVL 988-4 Electrolyte Analyzer

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K943702 ↗

FDA Product Code

JFP

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Avl Opti Critical Care Analyzer

  Class II

  FDA 510(k) K984299 Active Cleared 11 Dec 1998

• Avl Omni Modular Analyzer

  Class II

  FDA 510(k) K990092 Active Cleared 29 Jan 1999

• Avl Compact 1 Ph/Blood Gas Analyzer

  Class II

  FDA 510(k) K943570 Active Cleared 24 Aug 1994

• Avl Model 912 Co-Oxylite

  Class II

  FDA 510(k) K895466 Active Cleared 6 Nov 1989

• Avl Opti 1 Ph/Blood Gas Analyzer

  Class II

  FDA 510(k) K961161 Active Cleared 26 Apr 1996

• Avl Model 987 Electrolyte Analyzer

  Class II

  FDA 510(k) K891578 Active Cleared 22 May 1989

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• What types of clinical samples can the AVL 988-4 Electrolyte Analyzer measure, and how does it differ from other ion-specific analyzers?

  The AVL 988-4 Electrolyte Analyzer is specifically designed to measure electrolyte concentrations in serum, plasma, or urine samples, including sodium, potassium, chloride, and calcium. Unlike some general-purpose analyzers, this device focuses on ion-specific electrode technology, providing precise measurements for these key electrolytes in clinical chemistry laboratories. Its design ensures compatibility with these sample types while maintaining accuracy for critical diagnostic assessments.

• Is the AVL 988-4 Electrolyte Analyzer reusable, and what maintenance or calibration procedures are required?

  Yes, the AVL 988-4 is a reusable analytical instrument intended for long-term use in clinical settings like hospitals and laboratories. While it is not classified as single-use, each measurement is performed on a single sample per run. The manufacturer provides detailed calibration and maintenance instructions to ensure consistent performance, which must be followed as outlined in the device’s operational manual. Standard laboratory hygiene practices apply, but no special sterility conditions are required.

• What regulatory pathway was followed for the AVL 988-4 Electrolyte Analyzer, and how does this affect its use in clinical settings?

  The AVL 988-4 Electrolyte Analyzer was cleared through the FDA 510(k) process (K943702), specifically under the Traditional pathway, and is classified as a Class II device (regulation 862.1145). This clearance confirms its substantial equivalence to a predicate device, ensuring it meets FDA standards for safety and effectiveness in clinical chemistry applications. Clinicians can rely on its regulatory history when integrating it into laboratory workflows for electrolyte testing.

• Does the AVL 988-4 Electrolyte Analyzer have any special storage requirements, and is it compatible with MRI environments?

  The AVL 988-4 does not require special sterility conditions beyond standard laboratory hygiene, but it should be stored in a clean, dry environment as specified in the manufacturer’s guidelines to maintain optimal performance. Importantly, the device is not labeled as MRI-safe or unsafe, meaning it should not be used in MRI environments unless explicitly verified by the manufacturer for a specific model or configuration. Always check the device’s documentation for MRI-related warnings.