Cleared Traditional

K813369 - GRAM STAIN REAGENTS AND KIT

K813369 is an FDA 510(k) clearance for GRAM STAIN REAGENTS AND KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Hematology device with product code JTS cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K813369 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Dec 1981
Decision
22d
Days
Class 1
Risk

K813369 is an FDA 510(k) clearance for the GRAM STAIN REAGENTS AND KIT. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - the FDA hematology 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K813369

510(k) Number K813369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date December 22, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

JTS Device Classification - Class 1, General Controls

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - JTS Stains, Microbiologic

All 33
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K813369.
GRAM STAIN
K843050 · Reagent Laboratory, Inc. · Sep 1984
TRICHROME STAIN
K831060 · American Micro Scan · Jun 1983
FAST VIOLET B
K821038 · Dms Laboratories · May 1982
AFB STAIN SET
K812668 · Carr-Scarborough Microbiologicals, Inc. · Sep 1981
ACCRA-LAB GRAM STAIN SET 55760
K811780 · Accra Laboratories, Inc. · Jul 1981
DROPPERS, SOLUTION, IODINE
K781061 · Marion Laboratories, Inc. · Aug 1978