Cleared Traditional

K951435 - AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL

K951435 is an FDA 510(k) clearance for AALTO SCIENTIFIC SWEAT CHLORIDE REFEREN..., manufactured by Aalto Scientific, Ltd.. The device is a Class 1 Chemistry device with product code JJR cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K951435 · Aalto Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
36d
Days
Class 1
Risk

K951435 is an FDA 510(k) clearance for the AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Aalto Scientific, Ltd. (Vista, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 36 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K951435

510(k) Number K951435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date May 02, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

JJR Device Classification - Class 1, General Controls

Product Code JJR Electrolyte Controls (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 - JJR Electrolyte Controls (assayed And Unassayed)

All 11
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K951435.
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
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ELECTROLYTE STANDARDS
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SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · Quantimetrix Corp. · Oct 1994
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
K902266 · Phoenix Diagnostics, Inc. · Jun 1990
CIBA CORNING CERTAIN LYTE
K894576 · Ciba Corning Diagnostics Corp. · Oct 1989