Cleared Traditional

K871341 - QM300 CALIBRATOR A PACK

K871341 is the FDA 510(k) clearance for QM300 CALIBRATOR A PACK by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 2 Immunology device (product code JIX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871341 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
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May 1987
Decision
49d
Days
Class 2
Risk

K871341 is an FDA 510(k) clearance for the QM300 CALIBRATOR A PACK. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special 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 862.1150 - 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

Submission Details

510(k) Number K871341 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
55d faster than avg
Panel avg: 104d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K871341.
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K873118 · Biotrol, USA, Inc. · Sep 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · Em Diagnostic Systems, Inc. · May 1987
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
K871664 · Instrumentation Laboratory CO · May 1987
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
K864909 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1987