Cleared Traditional

K935611 - AXSYM LUTEINIZING HORMONE (LH)

K935611 is an FDA 510(k) clearance for AXSYM LUTEINIZING HORMONE (LH), manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K935611

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.

JJX Device Classification - Class 1, General Controls

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 397
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K935611.
TNT TROPONIN T
K942632 · Streck Laboratories, Inc. · Sep 1994
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
K942284 · Creative Laboratory Products, Inc. · Aug 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · Hichem Diagnostics · Aug 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · Heraeus Kulzer, Inc. · Jun 1994
ASSURE URINE HCG CONTROL
K941130 · Quantimetrix Corp. · Jun 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · Analytical Control Systems, Inc. · Apr 1994