Cleared Traditional

K881361 - SOLID PHASE EXTRACTION TUBES

K881361 is an FDA 510(k) clearance for SOLID PHASE EXTRACTION TUBES, manufactured by Supelco, Inc.. The device is a Class 1 Toxicology device with product code DJY cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K881361 · Supelco, Inc. · Toxicology device
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Aug 1988
Decision
174d
Days
Class 1
Risk

K881361 is an FDA 510(k) clearance for the SOLID PHASE EXTRACTION TUBES. Classified as Ion-exchange Chromatography (product code DJY), Class I - General Controls.

Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 174 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2230 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Supelco, Inc. devices

FDA 510(k) Submission Details - K881361

510(k) Number K881361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date August 08, 1988
Days to Decision 174 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 87d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

DJY Device Classification - Class 1, General Controls

Product Code DJY Ion-exchange Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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 - DJY Ion-exchange Chromatography

Devices cleared under the same product code (DJY) and FDA review panel - the closest regulatory comparables to K881361.
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K883615 · Supelco, Inc. · Dec 1988
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K830692 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1983
DUPONT PREP TYPE AS EXTRACTION CARTRIDE
K830693 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1983
PREP TYPE A EXTRACTION CARTRIDGE
K823697 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1983