Cleared Traditional

K781702 - CALIBRATOR

K781702 is the FDA 510(k) clearance for CALIBRATOR by Bio-Reagents & Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781702 · Bio-Reagents & Diagnostics, Inc. · Chemistry device
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Nov 1978
Decision
36d
Days
Class 2
Risk

K781702 is an FDA 510(k) clearance for the CALIBRATOR, BOVINE SERUM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Bio-Reagents & Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1978 after a review of 36 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 Bio-Reagents & Diagnostics, Inc. devices

Submission Details

510(k) Number K781702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1978
Decision Date November 15, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 230
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K781702.
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
K791874 · Gilford Diagnostics · Oct 1979
CALIBRATOR I
K791693 · Hi Chem, Inc. · Sep 1979
CALIBRATOR II
K791694 · Hi Chem, Inc. · Sep 1979
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553 · Beckman Instruments, Inc. · May 1978
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A
K770010 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B
K770011 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1977