Cleared Traditional

K863127 - TESTPACK ACUTE HCG URINGE CONTROLS

K863127 is an FDA 510(k) clearance for TESTPACK ACUTE HCG URINGE CONTROLS, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K863127 · Abbott Laboratories · Chemistry device
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Sep 1986
Decision
31d
Days
Class 1
Risk

K863127 is an FDA 510(k) clearance for the TESTPACK ACUTE HCG URINGE CONTROLS. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 15, 1986 after a review of 31 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K863127

510(k) Number K863127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 15, 1986
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JJW Device Classification - Class 1, General Controls

Product Code JJW Urinalysis 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 - JJW Urinalysis Controls (assayed And Unassayed)

All 39
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K863127.
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · Bio-Rad · Dec 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496 · Bio-Rad · Mar 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495 · Bio-Rad · Mar 1988
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756 · Texas Immunology, Inc. · Jul 1986
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565 · Icl Scientific · Oct 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · Sigma Chemical Co. · Sep 1984