Cleared Traditional

PATHO DX LATEX AGGLUTINATION STREP B KIT (K845022) - FDA 510(k) Clearance

Class I Microbiology device.

K845022 · Diagnostic Products Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
126d
Days
Class 1
Risk

K845022 is an FDA 510(k) clearance for the PATHO DX LATEX AGGLUTINATION STREP B KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 2, 1985 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K845022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date May 02, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 102d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 104
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K845022.
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories · Mar 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · Abbott Laboratories · Jan 1996
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
ABBOTT TEST PACK STREP A TEST
K945571 · Abbott Laboratories · Aug 1995
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories · Jul 1992
BBL STREP GROUPING KIT
K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1992