Cleared Traditional

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) (K871811) - FDA 510(k) Clearance

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

K871811 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
18d
Days
Class 2
Risk

K871811 is an FDA 510(k) clearance for the SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA). 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 May 26, 1987 after a review of 18 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

Submission Details

510(k) Number K871811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date May 26, 1987
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K871811.
PARAMAX CALCIUM REAGENT
K873519 · Baxter Healthcare Corp · Dec 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306 · Boehringer Mannheim Corp. · Aug 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
K871152 · Sigma Diagnostics, Inc. · Jun 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · Em Diagnostic Systems, Inc. · Mar 1987
VISION (TM) CALCIUM
K863670 · Abbott Laboratories · Nov 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · Em Diagnostic Systems, Inc. · Sep 1986