Cleared Traditional

K972012 - CHOLESTECH BUN/CREATININE TEST SYSTEM

K972012 is an FDA 510(k) clearance for CHOLESTECH BUN/CREATININE TEST SYSTEM, manufactured by Cholestech Corp.. The device is a Class 2 Chemistry device with product code CDN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K972012 · Cholestech Corp. · Chemistry device
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Jul 1997
Decision
55d
Days
Class 2
Risk

K972012 is an FDA 510(k) clearance for the CHOLESTECH BUN/CREATININE TEST SYSTEM. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Cholestech Corp. devices

FDA 510(k) Submission Details - K972012

510(k) Number K972012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date July 24, 1997
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDN Device Classification - Class 2, Special Controls

Product Code CDN Urease, Photometric, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDN Urease, Photometric, Urea Nitrogen

All 13
Devices cleared under the same product code (CDN) and FDA review panel - the closest regulatory comparables to K972012.
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · Alfa Wassermann Diagnostic Technologies, Inc. · Aug 2012
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
K103615 · Alfa Wassermann Diagnostic Technologies, Inc. · Sep 2011
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885 · Ortho-Clinical Diagnostics, Inc. · Jul 2000
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
BUN QVET
K943042 · Prisma Systems · Dec 1994
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · King Diagnostics, Inc. · Oct 1992