Cleared Traditional

INSTAREAD LITHIUM SYSTEM (K031579) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031579 · Akers Laboratories, Inc. · Toxicology device
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Dec 2003
Decision
213d
Days
Class 2
Risk

K031579 is an FDA 510(k) clearance for the INSTAREAD LITHIUM SYSTEM. Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Akers Laboratories, Inc. (Thorofare, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 213 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3560 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Akers Laboratories, Inc. devices

Submission Details

510(k) Number K031579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date December 19, 2003
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - JIH Flame Photometry, Lithium

All 11
Devices cleared under the same product code (JIH) and FDA review panel - the closest regulatory comparables to K031579.
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · Dade Behring, Inc. · Jun 2001
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · Eastman Kodak Company · Apr 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · Eastman Kodak Company · Jan 1993
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · Baxter Healthcare Corp · Dec 1989
TDX(R) LITES(TM) LITHIUM
K894328 · Abbott Laboratories · Nov 1989