Cleared Traditional

K855040 - SERALYZER TOTAL BILIRUBIN CALIBRATORS

K855040 is the FDA 510(k) clearance for SERALYZER TOTAL BILIRUBIN CALIBRATORS by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K855040 · Miles Laboratories, Inc. · Chemistry device
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Jan 1986
Decision
36d
Days
Class 2
Risk

K855040 is an FDA 510(k) clearance for the SERALYZER TOTAL BILIRUBIN CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 36 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K855040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date January 22, 1986
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 K855040.
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
TOTAL BILIRUBIN STANDARDS
K852068 · Data Medical Associates, Inc. · May 1985
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp. · Dec 1984
CHLORIDE STANDARD
K844235 · Shaban Mfg. Co. · Nov 1984