Cleared Traditional

K061549 - AMNIOSTAT-FLM-PG

K061549 is an FDA 510(k) clearance for AMNIOSTAT-FLM-PG, manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Chemistry device with product code JHG cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K061549 · Irvine Scientific Sales Co., Inc. · Chemistry device
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Oct 2006
Decision
135d
Days
Class 2
Risk

K061549 is an FDA 510(k) clearance for the AMNIOSTAT-FLM-PG. Classified as Chromatographic Separation, Lecithin/sphingomyelin Ratio (product code JHG), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 18, 2006 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1455 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K061549

510(k) Number K061549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date October 18, 2006
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHG Device Classification - Class 2, Special Controls

Product Code JHG Chromatographic Separation, Lecithin/sphingomyelin Ratio
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1455
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 Chemistry devices follow this clearance model.