Cleared Traditional

K881430 - LIQUI-SERA SERUM ALCOHOL CONTROLS

K881430 is an FDA 510(k) clearance for LIQUI-SERA SERUM ALCOHOL CONTROLS, manufactured by Biodiagnostic Intl. The device is a Class 1 Toxicology device with product code JJX cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K881430 · Biodiagnostic Intl · Toxicology device
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Jul 1988
Decision
94d
Days
Class 1
Risk

K881430 is an FDA 510(k) clearance for the LIQUI-SERA SERUM ALCOHOL CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Biodiagnostic Intl (La Habra, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biodiagnostic Intl devices

FDA 510(k) Submission Details - K881430

510(k) Number K881430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date July 08, 1988
Days to Decision 94 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 87d · This submission: 94d
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 461
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K881430.
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BILE ACIDS CONTROLS
K873342 · Sigma Diagnostics, Inc. · Oct 1987
TRI-LEVEL LIGAND CONTROL
K873450 · Ciba Corning Diagnostics Corp. · Sep 1987