Cleared Traditional

K902220 - PRECIPATH IM NORMAL & ABNORMAL IMMUNO. ...

K902220 is an FDA 510(k) clearance for PRECIPATH IM NORMAL & ABNORMAL IMMUNO. ..., manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Immunology device with product code DGR cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K902220 · Boehringer Mannheim Corp. · Immunology device
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Sep 1990
Decision
111d
Days
Class 1
Risk

K902220 is an FDA 510(k) clearance for the PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL. Classified as Whole Human Serum, Antigen, Antiserum, Control (product code DGR), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5700 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K902220

510(k) Number K902220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1990
Decision Date September 05, 1990
Days to Decision 111 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
7d slower than avg
Panel avg: 104d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

DGR Device Classification - Class 1, General Controls

Product Code DGR Whole Human Serum, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5700
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.