Cleared Traditional

ALATOP (TM) CATALOG # AKAL1 (K892197) - FDA 510(k) Clearance

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

K892197 · Diagnostic Products Corp. · Immunology device
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Jun 1989
Decision
60d
Days
Class 2
Risk

K892197 is an FDA 510(k) clearance for the ALATOP (TM) CATALOG # AKAL1. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K892197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date June 02, 1989
Days to Decision 60 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
44d faster than avg
Panel avg: 104d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 113
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K892197.
Kenota 1 Total IgE
K231151 · Kenota, Inc. · May 2024
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Total Immunoglobulin E (IgE)
K220178 · Beckman Coulter, Inc. · Mar 2022
ADVIA Centaur Total IgE (tIgE)
K193493 · Siemens Healthcare Diagnostics, Inc. · Jan 2020
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc. · Feb 2007
N LATEX IGE MONO REAGENT
K991787 · Dade Behring, Inc. · Jul 1999