Cleared Traditional

K874413 - REAGENT A AND REAGENT B

K874413 is the FDA 510(k) clearance for REAGENT A AND REAGENT B by Seradyn, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K874413 · Seradyn, Inc. · Chemistry device
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Jan 1988
Decision
69d
Days
Class 2
Risk

K874413 is an FDA 510(k) clearance for the REAGENT A AND REAGENT B. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seradyn, Inc. devices

Submission Details

510(k) Number K874413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date January 05, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K874413.
BIOTROL CALIBRANT LEVEL 2
K875304 · Biotrol, USA, Inc. · Feb 1988
BIOTROL CALIBRANT LEVEL 1
K875288 · Biotrol, USA, Inc. · Feb 1988
BIOTROL CALIBRANT LEVEL 3
K875318 · Biotrol, USA, Inc. · Feb 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · Baxter Healthcare Corp · Jan 1988
PROTEIN STANDARD CALIBRATOR
K871755 · Wako Chemicals USA, Inc. · Nov 1987
PARAMAX URINE/CSF CALIBRATOR
K872789 · American Dade · Sep 1987