Cleared Traditional

K830469 - BILIRUBIN STANDARD-LYOPHILIZED

K830469 is an FDA 510(k) clearance for BILIRUBIN STANDARD-LYOPHILIZED, manufactured by Dow Instruments & Reagents, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K830469 · Dow Instruments & Reagents, Inc. · Chemistry device
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Mar 1983
Decision
37d
Days
Class 2
Risk

K830469 is an FDA 510(k) clearance for the BILIRUBIN STANDARD-LYOPHILIZED. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dow Instruments & Reagents, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 37 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 Dow Instruments & Reagents, Inc. devices

FDA 510(k) Submission Details - K830469

510(k) Number K830469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date March 24, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 219
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K830469.
ACA THYROXINE UPTAKE CALIBRATOR
K833702 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
ACA THYROXINE CALIBRATOR
K833700 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
BILIRUBIN CALIBRATORS & CONTROL
K832094 · Gilford Diagnostics · Aug 1983
TRIGLYCERIDE CALIBRATOR
K822852 · Harleco Diagnostics · Oct 1982
SERA CHEM SMAC CALIBRATORS
K822496 · Fisher Scientific Co., LLC · Sep 1982
TOTAL PROTEIN STANDARD, #65074
K822475 · Emd Chemicals, Inc. · Sep 1982