Cleared Traditional

K842839 - SERIMM SURE ASO-CHEK CONTROL SERUM

K842839 is an FDA 510(k) clearance for SERIMM SURE ASO-CHEK CONTROL SERUM, manufactured by Analytical Products, Inc.. The device is a Class 1 Immunology device with product code GTQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K842839 · Analytical Products, Inc. · Immunology device
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Aug 1984
Decision
34d
Days
Class 1
Risk

K842839 is an FDA 510(k) clearance for the SERIMM SURE ASO-CHEK CONTROL SERUM. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1984 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3720 - 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K842839

510(k) Number K842839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date August 23, 1984
Days to Decision 34 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
71d faster than avg
Panel avg: 105d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GTQ Device Classification - Class 1, General Controls

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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 - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 23
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K842839.
LASER ASO KIT
K854039 · Behring Diagnostics, Inc. · Oct 1985
V-TREND ASO PLUS LATEX TEST
K853857 · Texas Immunology, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985
ASO-CHECK
K831464 · Diagnostic Technology, Inc. · Jun 1983
ASO SURE
K820785 · Analytical Products, Inc. · Apr 1982
ASO SURE PLUS
K820786 · Analytical Products, Inc. · Apr 1982