Cleared Traditional

K870151 - TOTAL/IGE THEOPHYLLINE CONTROL SERA

K870151 is the FDA 510(k) clearance for TOTAL/IGE THEOPHYLLINE CONTROL SERA by 3M Company. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K870151 · 3M Company · Immunology device
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Mar 1987
Decision
58d
Days
Class 1
Risk

K870151 is an FDA 510(k) clearance for the TOTAL/IGE THEOPHYLLINE CONTROL SERA. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by 3M Company (Mountain View, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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: 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 3M Company devices

Submission Details

510(k) Number K870151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date March 12, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 104d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K870151.
BILE ACIDS CONTROLS
K873342 · Sigma Diagnostics, Inc. · Oct 1987
TRI-LEVEL LIGAND CONTROL
K873450 · Ciba Corning Diagnostics Corp. · Sep 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105 · Streck Laboratories, Inc. · Sep 1987
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · Abbott Laboratories · Sep 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · Em Diagnostic Systems, Inc. · Apr 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · Sigma Diagnostics, Inc. · Feb 1986