Cleared Traditional

K871342 - QM2/QM300 CONTROL A PACK

K871342 is an FDA 510(k) clearance for QM2/QM300 CONTROL A PACK, manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871342 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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May 1987
Decision
49d
Days
Class 1
Risk

K871342 is an FDA 510(k) clearance for the QM2/QM300 CONTROL A PACK. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 49 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

FDA 510(k) Submission Details - K871342

510(k) Number K871342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1987
Decision Date May 21, 1987
Days to Decision 49 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
56d faster than avg
Panel avg: 105d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K871342.
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
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DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
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LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
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LIQUID CHEMISTRY CONTROL, LEVEL II
K870683 · U. S. Diagnostics, Inc. · Apr 1987
LIQUID CHEMISTRY CONTROL, LEVEL I
K870684 · U. S. Diagnostics, Inc. · Apr 1987
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
K871058 · Fisher Scientific Co., LLC · Apr 1987