Cleared Traditional

K924509 - CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION

K924509 is an FDA 510(k) clearance for CALCIUM CHLORIDE/DIETHYLBARB ACETATE BU..., manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K924509 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
108d
Days
Class 2
Risk

K924509 is an FDA 510(k) clearance for the CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K924509

510(k) Number K924509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date December 21, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 113d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K924509.
COAGULATION CONTROL CONTAINING HEMOGLOBIN
K925340 · Analytical Control Systems, Inc. · Mar 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
K923761 · International Technidyne Corp. · Jan 1993
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · Organon Teknika Corp. · Dec 1992
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992
STANDARD HUMAN PLASMA
K924393 · Behring Diagnostics, Inc. · Nov 1992