Cleared Traditional

K991111 - BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02

K991111 is an FDA 510(k) clearance for BUFFER CHROMOGEN (R1), manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K991111 · A.P. Total Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
54d
Days
Class 2
Risk

K991111 is an FDA 510(k) clearance for the BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA.... Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999 after a review of 54 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991111

510(k) Number K991111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date May 25, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
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 89
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K991111.
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009 · Hemagen Diagnostics, Inc. · Jun 2004
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · Wiener Laboratories Saic · Dec 2001
RANDOX CALCIUM
K000375 · Randox Laboratories, Ltd. · Apr 2000
CALCIUM REAGENT
K971907 · Carolina Liquid Chemistries Corp. · Jun 1997
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292 · Roche Diagnostic Systems, Inc. · Oct 1996
CALCIUM REAGENT
K955939 · Derma Media Lab., Inc. · Mar 1996