Cleared Traditional

K842327 - AMER. HISTO-ID SYS PRIMARY IGM S7920-31 (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842327 · Bartels Immunodiagnostic Supplies, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
50d
Days
Class 2
Risk

K842327 is an FDA 510(k) clearance for the AMER. HISTO-ID SYS PRIMARY IGM S7920-31. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K842327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date August 02, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 104d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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.