Cleared Traditional

K760597 - BIOTROL-NORMAL

K760597 is an FDA 510(k) clearance for BIOTROL-NORMAL, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K760597 · Boehringer Mannheim Corp. · Hematology device
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Oct 1976
Decision
31d
Days
Class 2
Risk

K760597 is an FDA 510(k) clearance for the BIOTROL-NORMAL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1976 after a review of 31 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K760597

510(k) Number K760597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1976
Decision Date October 08, 1976
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

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 148
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K760597.
PLATELET-CHEX-HUMAN
K770020 · Streck Laboratories, Inc. · Feb 1977
PLATELET CONTROLS, NORMAL & ABNORMAL
K760549 · Dade, Baxter Travenol Diagnostics, Inc. · Oct 1976
BIOTROL-ABNORMAL
K760596 · Boehringer Mannheim Corp. · Oct 1976
4C ABNORMAL LOW-HIGH (8 X 6 M1)
K760682 · Coulter Electronics, Inc. · Oct 1976