Cleared Traditional

K871185 - LITHIUM INTERNAL STANDARD 1 MEQ/L #60085

K871185 is the FDA 510(k) clearance for LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 by In Vitro Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K871185 · In Vitro Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
65d
Days
Class 2
Risk

K871185 is an FDA 510(k) clearance for the LITHIUM INTERNAL STANDARD 1 MEQ/L #60085. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by In Vitro Diagnostics, Inc. (Shelton, US). The FDA issued a Cleared decision on May 28, 1987 after a review of 65 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 In Vitro Diagnostics, Inc. devices

Submission Details

510(k) Number K871185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date May 28, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 94
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K871185.
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · Reagents Applications, Inc. · Aug 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · Terumo Medical Corp. · Jun 1988
CALCIUM CALIBRATOR
K872051 · Wako Chemicals USA, Inc. · Sep 1987
ISE COMPENSATION SERA
K870379 · Boehringer Mannheim Corp. · Feb 1987
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · Em Diagnostic Systems, Inc. · Aug 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · Em Diagnostic Systems, Inc. · Aug 1986