Cleared Traditional

K813447 - SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR

K813447 is the FDA 510(k) clearance for SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR by Rna Medical Corp.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K813447 · Rna Medical Corp. · Chemistry device
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Dec 1981
Decision
30d
Days
Class 2
Risk

K813447 is an FDA 510(k) clearance for the SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Rna Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 30 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 Rna Medical Corp. devices

Submission Details

510(k) Number K813447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date December 31, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 94
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K813447.
BECKMAN URIC ACID STANDARD
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SYVA ADVANCE STANDARDIZATION KIT 01
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FLAME PHOTOMETER CALIBRATION STANDARDS
K813505 · Fisher Scientific Co., LLC · Dec 1981
TRIGLYCERIDE CALIBRATORS
K813478 · Gilford Diagnostics · Dec 1981
CHOLESTEROL CALIBRATORS
K812861 · Gilford Diagnostics · Oct 1981