Cleared Traditional

K873342 - BILE ACIDS CONTROLS

K873342 is the FDA 510(k) clearance for BILE ACIDS CONTROLS by Sigma Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K873342 · Sigma Diagnostics, Inc. · Chemistry device
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Oct 1987
Decision
62d
Days
Class 1
Risk

K873342 is an FDA 510(k) clearance for the BILE ACIDS CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K873342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1987
Decision Date October 20, 1987
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K873342.
QTEST PREGNANCY TEST CONTROL
K883741 · Quidel Corp. · Oct 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · Quidel Corp. · Sep 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · Sigma Diagnostics, Inc. · Feb 1988
TRI-LEVEL LIGAND CONTROL
K873450 · Ciba Corning Diagnostics Corp. · Sep 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105 · Streck Laboratories, Inc. · Sep 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151 · 3M Company · Mar 1987