Cleared Traditional

K041871 - INTERLAB MICROCAL SERUM CONTROLS

K041871 is an FDA 510(k) clearance for INTERLAB MICROCAL SERUM CONTROLS, manufactured by Trouble Shooter Consuling, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K041871 · Trouble Shooter Consuling, Inc. · Chemistry device
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Aug 2004
Decision
38d
Days
Class 1
Risk

K041871 is an FDA 510(k) clearance for the INTERLAB MICROCAL SERUM CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Trouble Shooter Consuling, Inc. (Rome, IT). The FDA issued a Cleared decision on August 16, 2004 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trouble Shooter Consuling, Inc. devices

FDA 510(k) Submission Details - K041871

510(k) Number K041871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2004
Decision Date August 16, 2004
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 435
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