Cleared Traditional

K842991 - AUTOFLUOR V SYSTEM

K842991 is an FDA 510(k) clearance for AUTOFLUOR V SYSTEM, manufactured by Tech America Diagnostics. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K842991 · Tech America Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
227d
Days
Class 2
Risk

K842991 is an FDA 510(k) clearance for the AUTOFLUOR V SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Tech America Diagnostics (San Marcos, US). The FDA issued a Cleared decision on March 14, 1985 after a review of 227 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tech America Diagnostics devices

FDA 510(k) Submission Details - K842991

510(k) Number K842991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date March 14, 1985
Days to Decision 227 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 105d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 72
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K842991.
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
ANTI-DNA MICROASSAY
K863717 · Diamedix Corp. · Oct 1986
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 1986
COLORZYME NDNA TEST SYSTEM
K843225 · Immuno Concepts, Inc. · Nov 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · Behring Diagnostics, Inc. · Jun 1984