Cleared Traditional

K840299 - PH ELECTRODE CALIBRATING BUFFERS-BLOOD

K840299 is the FDA 510(k) clearance for PH ELECTRODE CALIBRATING BUFFERS-BLOOD by Bionostics, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K840299 · Bionostics, Inc. · Chemistry device
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Mar 1984
Decision
59d
Days
Class 2
Risk

K840299 is an FDA 510(k) clearance for the PH ELECTRODE CALIBRATING BUFFERS-BLOOD. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Bionostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 59 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

Submission Details

510(k) Number K840299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 23, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 75
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K840299.
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp. · Dec 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · Boehringer Mannheim Corp. · Aug 1983
CALCIUM STANDARD, ITEM #65075
K822473 · Emd Chemicals, Inc. · Sep 1982
CREATININE STANDARD #65072
K822477 · Emd Chemicals, Inc. · Sep 1982