Selectra Prom/Elical 2/ELITROL I and Elitrol II/AST/GOT 4+1 SL/Potassium, Sodium, Chloride

• • Terminated Z-2764-2019 FDA Class III ·initiated 12 Jul 2016 ·on shared 510(k) K102647

  Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

• • Terminated Z-0006-2015 FDA Class III ·initiated 11 Aug 2014 ·on shared 510(k) K102647

  Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.

• 2 recalls, same reason

  • Terminated Z-0158-2020 FDA Class II ·initiated 10 Jan 2012
  • Terminated Z-0157-2020 FDA Class II ·initiated 10 Jan 2012

  The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 Sl/Potassium, Sodium, Chloride...

510(k) Number

K102647 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• What clinical applications does this device support in a laboratory setting?

  This device supports quantitative analysis of sodium, potassium, and chloride ion concentrations in clinical samples, which are critical for assessing electrolyte balance and metabolic health. It is specifically designed for use with ELITech Clinical Systems analyzers to calibrate and perform quality control checks on ion-specific assays, ensuring accurate diagnostic results for patients.

• Are the calibrators and quality control sera single-use or reusable?

  The calibrators (Elical 2) and quality control sera (Elitrol I and II) are supplied as lyophilized human serum-based products, which are intended for single-use only in clinical laboratories. This design ensures precision and avoids cross-contamination between samples.

• How should these reagents be stored, and what are the key handling considerations?

  The lyophilized reagents must be stored and handled according to standard laboratory protocols for lyophilized products. This typically includes refrigeration (e.g., 2–8°C) until use and protection from moisture or extreme temperatures. Since they are single-use, proper labeling and inventory tracking are essential to prevent expiration or misuse.

• What regulatory pathways does this device follow, and how does that affect its use?

  The device is cleared under FDA 510(k) (K102647) and complies with IVDR (In Vitro Diagnostic Regulation) requirements. This means it has undergone evaluation for safety and performance in clinical chemistry applications, but it does not imply any restrictions on its use beyond standard laboratory practices. Always follow manufacturer instructions and local regulatory guidelines for implementation.

• Can this system be integrated with other analyzers, or is it limited to ELITech Clinical Systems?

  The device is specifically designed to integrate with ELITech Clinical Systems analyzers (e.g., the Selectra Prom system) for calibration and quality control of ion-specific assays. While it may not be compatible with non-ELITech systems, its primary function relies on this integration to ensure accurate and standardized results for electrolyte measurements.