Cleared Traditional

K861314 - CHOLESTEROL CALIBRATORS

K861314 is the FDA 510(k) clearance for CHOLESTEROL CALIBRATORS by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K861314 · Sigma Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
84d
Days
Class 2
Risk

K861314 is an FDA 510(k) clearance for the CHOLESTEROL CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 84 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K861314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date July 01, 1986
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
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 K861314.
URIC ACID STANDARD SOLUTION CALIBRATOR
K871768 · Wako Chemicals USA, Inc. · May 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1987
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525 · Em Diagnostic Systems, Inc. · Aug 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
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
K851670 · Medical Analysis Systems, Inc. · May 1985