Cleared Traditional

K862704 - EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR ...

K862704 is the FDA 510(k) clearance for EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR ... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K862704 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1986
Decision
35d
Days
Class 2
Risk

K862704 is an FDA 510(k) clearance for the EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 35 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K862704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date August 19, 1986
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K862704.
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
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · Miles Laboratories, Inc. · Jan 1986
TOTAL BILIRUBIN STANDARDS
K852068 · Data Medical Associates, Inc. · May 1985
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp. · Dec 1984