Cleared Traditional

BIOSCAN E12 (K781421) - FDA 510(k) Clearance

Class I Chemistry device.

K781421 · Clinifax Industries, Ltd. · Chemistry device
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Sep 1978
Decision
34d
Days
Class 1
Risk

K781421 is an FDA 510(k) clearance for the BIOSCAN E12. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Clinifax Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Clinifax Industries, Ltd. devices

Submission Details

510(k) Number K781421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1978
Decision Date September 20, 1978
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJS Controls For Blood-gases, (assayed And Unassayed)

All 14
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K781421.
FETAL-TEK CONTROL MATURE
K820319 · Helena Laboratories · Mar 1982
PATHWAY PH BLOOD GAS CONTROL
K820103 · Beckman Instruments, Inc. · Jan 1982
PH/BLOOD GAS CONTROL (ABC)
K811143 · Instrumentation Laboratory CO · May 1981
AQUEOUS PH/BLOOD GAS CONTROLS
K770228 · Instrumentation Laboratory CO · Jun 1977