FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a 510(k) clearance letter from the FDA for a medical device called the "EasyLyte Quality Control Kit." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a performance study for an AI/ML medical device would.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance is based on its substantial equivalence to existing, legally marketed predicate devices, not on a new study demonstrating its performance against specific acceptance criteria for a novel technology or AI algorithm.

Therefore, I cannot provide the requested information because it is not contained within the provided text. The document is a regulatory approval notice, not a clinical or performance study report.

Ask a Question

Ask a specific question about this device

K Number

K960592

Device Name

ELECTROLYTE STANDARDS

Manufacturer

PHOENIX DIAGNOSTICS, INC.

Date Cleared

1996-05-13

(91 days)

Product Code