Cleared Traditional

K802109 - KEMTROL SERUM CONTROL ABNORMAL

K802109 is the FDA 510(k) clearance for KEMTROL SERUM CONTROL ABNORMAL by Helena Laboratories. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K802109 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
37d
Days
Class 1
Risk

K802109 is an FDA 510(k) clearance for the KEMTROL SERUM CONTROL ABNORMAL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 37 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 Helena Laboratories devices

Submission Details

510(k) Number K802109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date October 10, 1980
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K802109.
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952 · Corning Medical & Scientific · Apr 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098 · American Diagnostic Corp. · Jan 1981
KEMTROL SERUM CONTROL-NORMAL
K802108 · Helena Laboratories · Oct 1980
ASSURE LEVEL I PROD. #30171
K801538 · Warner-Lambert Co. · Sep 1980
ASSURE LEVEL II PROD. #30172
K801539 · Warner-Lambert Co. · Sep 1980
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE
K801335 · Warner-Lambert Co. · Jul 1980