Cleared Traditional

K872306 - SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM....

K872306 is an FDA 510(k) clearance for SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM...., manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K872306 · Boehringer Mannheim Corp. · Chemistry device
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Aug 1987
Decision
64d
Days
Class 2
Risk

K872306 is an FDA 510(k) clearance for the SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA). Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 18, 1987 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry 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 - K872306

510(k) Number K872306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date August 18, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIC Device Classification - Class 2, Special Controls

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIC Cresolphthalein Complexone, Calcium

All 69
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K872306.
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · Pointe Scientific, Inc., · Dec 1987
WAKO(TM) AUTOKIT CALCIUM
K873334 · Wako Chemicals USA, Inc. · Oct 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · Trace Scientific , Ltd. · Aug 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
K871152 · Sigma Diagnostics, Inc. · Jun 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811 · Boehringer Mannheim Corp. · May 1987
CALCIUM TEST
K870629 · Sclavo, Inc. · Apr 1987