Cleared Traditional

K851450 - FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM

K851450 is an FDA 510(k) clearance for FLUORESCENT MICROBEAD ALIGNMENT STANDAR..., manufactured by Flow Cytometry Standards Corp.. The device is a Class 2 Microbiology device with product code JIW cleared through the Traditional 510(k) pathway after a 158-day FDA review.

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

FDA 510(k) Submission Details - K851450

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.

JIW Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K851450.
CALIBRATION KIT
K882220 · King Diagnostics, Inc. · Aug 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · American Research Products Co. · Jun 1988
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
QUICK-CHEM CALIBRATION SET
K852260 · Seragen Diagnostics, Inc. · Jul 1985
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1981
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980