Cleared Traditional

K883411 - PG-NUMERIC(TM)

K883411 is an FDA 510(k) clearance for PG-NUMERIC(TM), manufactured by Isolab, Inc.. The device is a Class 2 Chemistry device with product code JHF cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K883411 · Isolab, Inc. · Chemistry device
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Mar 1989
Decision
212d
Days
Class 2
Risk

K883411 is an FDA 510(k) clearance for the PG-NUMERIC(TM). Classified as Colorimetric Method, Lecithin/sphingomyelin Ratio (product code JHF), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 212 days - an extended review cycle.

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 Isolab, Inc. devices

FDA 510(k) Submission Details - K883411

510(k) Number K883411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date March 15, 1989
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHF Device Classification - Class 2, Special Controls

Product Code JHF Colorimetric Method, 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.