Cleared Traditional

K852068 - TOTAL BILIRUBIN STANDARDS

K852068 is an FDA 510(k) clearance for TOTAL BILIRUBIN STANDARDS, manufactured by Data Medical Associates, Inc.. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K852068 · Data Medical Associates, Inc. · Chemistry device
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May 1985
Decision
21d
Days
Class 2
Risk

K852068 is an FDA 510(k) clearance for the TOTAL BILIRUBIN STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on May 31, 1985 after a review of 21 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K852068

510(k) Number K852068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1985
Decision Date May 31, 1985
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 112
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K852068.
PHENYTOIN (FPIA) CALIBRATOR KIT
K861770 · Windsor Laboratories, Inc. · Jun 1986
TOBRAMYCIN (FPIA) CALIBRATOR KIT
K861891 · Windsor Laboratories, Inc. · Jun 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · Miles Laboratories, Inc. · Jan 1986
80 MG/DL GLUCOSE CONTROL
K844581 · Boehringer Mannheim Corp. · Dec 1984
CHLORIDE STANDARD
K844235 · Shaban Mfg. Co. · Nov 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · Roche Diagnostic Systems, Inc. · Sep 1984