Cleared Traditional

K851670 - CHEM TRAK TRI-POINT LIQUID BILIRUBIN CA...

K851670 is the FDA 510(k) clearance for CHEM TRAK TRI-POINT LIQUID BILIRUBIN CA... by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K851670 · Medical Analysis Systems, Inc. · Chemistry device
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May 1985
Decision
17d
Days
Class 2
Risk

K851670 is an FDA 510(k) clearance for the CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 17 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K851670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date May 10, 1985
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K851670.
CHOLESTEROL CALIBRATORS
K861314 · Sigma Diagnostics, Inc. · Jul 1986
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
K852461 · Medical Analysis Systems, Inc. · Jul 1985
DIRECT BILIRUBEN CALIBRATIONS
K852067 · Data Medical Associates, Inc. · May 1985
TRIGLYCERIDE CALIBRATOR
K844468 · Sigma Diagnostics, Inc. · Dec 1984
ROCHE STANDARDS FOR URIC ACID
K843112 · Roche Diagnostic Systems, Inc. · Sep 1984
ACTH STANDARD MATRIX
K842099 · Diagnostic Systems Laboratories, Inc. · Aug 1984