Cleared Traditional

BIO SET TM SUBSTRATE CALIBRATORS (K810963) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810963 · Boehringer Mannheim Corp. · Chemistry device
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Apr 1981
Decision
9d
Days
Class 2
Risk

K810963 is an FDA 510(k) clearance for the BIO SET TM SUBSTRATE CALIBRATORS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 9 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K810963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date April 17, 1981
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K810963.
BECKMAN URIC ACID STANDARD
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ACE ALBUMIN CALIBRATOR
K821061 · E.I. Dupont DE Nemours & Co., Inc. · May 1982
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · Syva Co. · Apr 1982
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · Miles Laboratories, Inc. · Aug 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · Syva Co. · Jun 1980