Cleared Traditional

MNITROL HEMOTOL. REF. AND CONTROL (K770384) - FDA 510(k) Clearance

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

K770384 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1977
Decision
39d
Days
Class 2
Risk

K770384 is an FDA 510(k) clearance for the MNITROL HEMOTOL. REF. AND CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 8, 1977 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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

Submission Details

510(k) Number K770384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1977
Decision Date April 08, 1977
Days to Decision 39 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
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 32
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K770384.
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · American Dade · Oct 1980
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
K791030 · Beckman Instruments, Inc. · Jun 1979
COAGULATION ARP
K790826 · Helena Laboratories · May 1979
LATELET, CONTROL, NORMAL & ABNORMAL
K770386 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1977
PLATELET CONTROL, NORMAL & ABNORMAL
K770095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1977
BIOTROL-ABNORMAL
K760596 · Boehringer Mannheim Corp. · Oct 1976