Cleared Traditional

K971888 - GLUTATECT

K971888 is an FDA 510(k) clearance for GLUTATECT, manufactured by Alden Scientific, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K971888 · Alden Scientific, Inc. · General Hospital
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Jan 1998
Decision
233d
Days
Class 2
Risk

K971888 is an FDA 510(k) clearance for the GLUTATECT. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Alden Scientific, Inc. (West Springfield, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 233 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alden Scientific, Inc. devices

FDA 510(k) Submission Details - K971888

510(k) Number K971888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1997
Decision Date January 09, 1998
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 206
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K971888.
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K960441 · Steritec Products Mfg Co, Inc. · May 1997