Cleared Traditional

K921977 - SYNERGY SCREEN TEST, MODIFICATION (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921977 · Baxter Healthcare Corp · Microbiology device
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Oct 1993
Decision
539d
Days
Class 2
Risk

K921977 is an FDA 510(k) clearance for the SYNERGY SCREEN TEST, MODIFICATION. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K921977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date October 12, 1993
Days to Decision 539 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 102d · This submission: 539d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.