Cleared Traditional

K862087 - SANTEST 1AP

K862087 is an FDA 510(k) clearance for SANTEST 1AP, manufactured by Scientific Sales Intl., Inc.. The device is a Class 1 Immunology device with product code LKL cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K862087 · Scientific Sales Intl., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
184d
Days
Class 1
Risk

K862087 is an FDA 510(k) clearance for the SANTEST 1AP. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on December 3, 1986 after a review of 184 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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 Scientific Sales Intl., Inc. devices

FDA 510(k) Submission Details - K862087

510(k) Number K862087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1986
Decision Date December 03, 1986
Days to Decision 184 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 105d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

LKL Device Classification - Class 1, General Controls

Product Code LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
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 - LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (LKL) and FDA review panel - the closest regulatory comparables to K862087.
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · Reagents Applications, Inc. · Nov 1990
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · Technicon Instruments Corp. · Nov 1988
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · Unipath , Ltd. · Oct 1987
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · Kent Laboratories, Inc. · Jul 1983