Cleared Traditional

AXSYM LUTEINIZING HORMONE (LH) (K935611) - FDA 510(k) Clearance

Class I Chemistry device.

K935611 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
211d
Days
Class 1
Risk

K935611 is an FDA 510(k) clearance for the AXSYM LUTEINIZING HORMONE (LH). Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 211 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K935611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date June 21, 1994
Days to Decision 211 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 88d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 209
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K935611.
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SAS QUANT HCG URINE
K944891 · Sa Scientific, Inc. · Nov 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · Heraeus Kulzer, Inc. · Jun 1994
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744 · Sa Scientific, Inc. · Sep 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007 · Diagnostic Products Corp. · Aug 1993