Cleared Traditional

K882728 - AMERLITE ENDOCRINOLOGY CONTROL SERA LAN...

K882728 is the FDA 510(k) clearance for AMERLITE ENDOCRINOLOGY CONTROL SERA LAN... by Amersham Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K882728 · Amersham Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
97d
Days
Class 1
Risk

K882728 is an FDA 510(k) clearance for the AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 97 days - within the typical 510(k) review window.

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 Amersham Corp. devices

Submission Details

510(k) Number K882728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date October 06, 1988
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
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 479
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K882728.
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · Bio-Rad · Oct 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861 · Casco Standards · Oct 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736 · Amersham Corp. · Oct 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124 · Amersham Corp. · Sep 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · Amersham Corp. · Aug 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · Bio-Rad · Jul 1988