Cleared Traditional

K911059 - TURBIDOMETRIC STANDARD (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911059 · Scientific Device Laboratory, Inc. · Microbiology device
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Jun 1991
Decision
91d
Days
Class 2
Risk

K911059 is an FDA 510(k) clearance for the TURBIDOMETRIC STANDARD. Classified as Reagent/device, Inoculum Calibration (product code LIE), Class II - Special Controls.

Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientific Device Laboratory, Inc. devices

Submission Details

510(k) Number K911059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date June 10, 1991
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIE Reagent/device, Inoculum Calibration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Microbiology devices follow this clearance model.