Cleared Traditional

K904698 - SECONDARY CALIBRATORS

K904698 is an FDA 510(k) clearance for SECONDARY CALIBRATORS, manufactured by Bionostics, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K904698 · Bionostics, Inc. · Chemistry device
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Nov 1990
Decision
43d
Days
Class 2
Risk

K904698 is an FDA 510(k) clearance for the SECONDARY CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Bionostics, Inc. (Acton, US). The FDA issued a Cleared decision on November 28, 1990 after a review of 43 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 Bionostics, Inc. devices

FDA 510(k) Submission Details - K904698

510(k) Number K904698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1990
Decision Date November 28, 1990
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 207
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