Cleared Traditional

K873116 - MULTI ANALYTE MIXTURES, CALIBRATORS

K873116 is an FDA 510(k) clearance for MULTI ANALYTE MIXTURES, manufactured by Biotrol, USA, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K873116 · Biotrol, USA, Inc. · Chemistry device
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Sep 1987
Decision
23d
Days
Class 2
Risk

K873116 is an FDA 510(k) clearance for the MULTI ANALYTE MIXTURES, CALIBRATORS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Berwyn, US). The FDA issued a Cleared decision on September 2, 1987 after a review of 23 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.

FDA 510(k) Submission Details - K873116

510(k) Number K873116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date September 02, 1987
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

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 301
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K873116.
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
BIOTROL REFERENCE
K873118 · Biotrol, USA, Inc. · Sep 1987
FLAME PHOTOMETER STANDARD #60081 120 NA/2K
K871182 · In Vitro Diagnostics, Inc. · May 1987
FLAME PHOTOMETER STANDARD #60082 140 NA/5K
K871183 · In Vitro Diagnostics, Inc. · May 1987
K873116 · MULTI ANALYTE MIXTURES, CALIBRATORS
Download PDF Biotrol, USA, Inc.