Cleared Traditional

K897006 - PHARMACIA MUMPS IGG ELISA

K897006 is an FDA 510(k) clearance for PHARMACIA MUMPS IGG ELISA, manufactured by Pharmacia Eni Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJY cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K897006 · Pharmacia Eni Diagnostics, Inc. · Microbiology device
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Jul 1990
Decision
220d
Days
Class 1
Risk

K897006 is an FDA 510(k) clearance for the PHARMACIA MUMPS IGG ELISA. Classified as Enzyme Linked Immunoabsorbent Assay, Mumps Virus (product code LJY), Class I - General Controls.

Submitted by Pharmacia Eni Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 220 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3380 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia Eni Diagnostics, Inc. devices

FDA 510(k) Submission Details - K897006

510(k) Number K897006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date July 26, 1990
Days to Decision 220 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 102d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

LJY Device Classification - Class 1, General Controls

Product Code LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
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.