Cleared Traditional

K872073 - BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

K872073 is an FDA 510(k) clearance for BIO-INTERFERENCE BLANKING MATERIAL, manufactured by American Monitor Corp.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K872073 · American Monitor Corp. · Chemistry device
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Sep 1987
Decision
105d
Days
Class 2
Risk

K872073 is an FDA 510(k) clearance for the BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 105 days - within the typical 510(k) review window.

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: 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.

View all American Monitor Corp. devices

FDA 510(k) Submission Details - K872073

510(k) Number K872073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1987
Decision Date September 11, 1987
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

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 217
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K872073.
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
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