Cleared Traditional

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450) - FDA 510(k) Clearance

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

K851450 · Flow Cytometry Standards Corp. · Microbiology device
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Sep 1985
Decision
158d
Days
Class 2
Risk

K851450 is an FDA 510(k) clearance for the FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Flow Cytometry Standards Corp. (Research Triangle Park, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 158 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1150 - 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 Flow Cytometry Standards Corp. devices

Submission Details

510(k) Number K851450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date September 16, 1985
Days to Decision 158 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 102d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.

Regulatory Peers - JIW Calibrator, Surrogate

All 16
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K851450.
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · Diagnostic Products Corp. · Oct 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · Sigma Chemical Co. · Jul 1990
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980