Cleared Traditional

K880610 - UNIMETER CALIBRATION KIT

K880610 is an FDA 510(k) clearance for UNIMETER CALIBRATION KIT, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code JIW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K880610 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
41d
Days
Class 2
Risk

K880610 is an FDA 510(k) clearance for the UNIMETER CALIBRATION KIT. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 - K880610

510(k) Number K880610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1988
Decision Date March 24, 1988
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIW Device Classification - Class 2, Special Controls

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIW Calibrator, Surrogate

All 12
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K880610.
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · Reagents Applications, Inc. · Dec 1988
CALIBRATION KIT
K882220 · King Diagnostics, Inc. · Aug 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · American Research Products Co. · Jun 1988
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1981
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · Union Carbide Corp. · Mar 1980