Cleared Traditional

K781077 - CONTROL

K781077 is the FDA 510(k) clearance for CONTROL by Dade, Baxter Travenol Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K781077 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Jul 1978
Decision
29d
Days
Class 2
Risk

K781077 is an FDA 510(k) clearance for the CONTROL, HEMATOLOGY, CH-60. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 29 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 Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K781077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1978
Decision Date July 27, 1978
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
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 138
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K781077.
HEMOGLOBIN CONTROLS
K790457 · Data Medical Associates, Inc. · Apr 1979
HEMATROL S HEMATOLOGY CONTROLS
K790525 · Fisher Scientific Co., LLC · Apr 1979
BLOOD, HEMATOLOGY REFERENCE CONTROL
K781969 · Coulter Electronics, Inc. · Jan 1979
CELL-CHEX
K780140 · Streck Laboratories, Inc. · Mar 1978
HEMATOLOGY REFERENCE CONTROLS
K772195 · R&D Systems, Inc. · Feb 1978
HEMATOLOGY REFERENCE CONTROL
K771753 · Coulter Electronics, Inc. · Nov 1977