Cleared Traditional

K896875 - POSITIVE AND NEGATIVE HCG SERUM CONTROLS

K896875 is the FDA 510(k) clearance for POSITIVE AND NEGATIVE HCG SERUM CONTROLS by Armkel, LLC. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K896875 · Armkel, LLC · Chemistry device
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Feb 1990
Decision
80d
Days
Class 1
Risk

K896875 is an FDA 510(k) clearance for the POSITIVE AND NEGATIVE HCG SERUM CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 80 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 Armkel, LLC devices

Submission Details

510(k) Number K896875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date February 26, 1990
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
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 K896875.
AMERSHAM TSH CONTROL SERA
K902760 · Amersham Corp. · Jul 1990
CHEM-CHEX BILIRUBIN
K902867 · Streck Laboratories, Inc. · Jul 1990
ROTAG CONTROLS
K900719 · Roche Diagnostic Systems, Inc. · May 1990
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528 · Helena Laboratories · Oct 1989
MICRO-PLATE READER, MDX-1
K894400 · Medix Biotech, Inc. · Oct 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804 · Lifescan, Inc. · Sep 1989