Cleared Traditional

K121985 - ARCHITECT TOTAL BILIRUBIN (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121985 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
210d
Days
Class 2
Risk

K121985 is an FDA 510(k) clearance for the ARCHITECT TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 210 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K121985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2012
Decision Date February 01, 2013
Days to Decision 210 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 234
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K121985.
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022