Cleared Traditional

K875288 - BIOTROL CALIBRANT LEVEL 1

K875288 is the FDA 510(k) clearance for BIOTROL CALIBRANT LEVEL 1 by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K875288 · Biotrol, USA, Inc. · Chemistry device
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Feb 1988
Decision
35d
Days
Class 2
Risk

K875288 is an FDA 510(k) clearance for the BIOTROL CALIBRANT LEVEL 1. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 35 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K875288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date February 02, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 204
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K875288.
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · Baxter Healthcare Corp · May 1988
QM300 CALIBRATOR B PACK
K875282 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
BIOTROL CALIBRANT LEVEL 2
K875304 · 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