Cleared Traditional

K821934 - BIO-CAL OPERATION CHECK KIT

K821934 is the FDA 510(k) clearance for BIO-CAL OPERATION CHECK KIT by Bio-Analytics Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K821934 · Bio-Analytics Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
21d
Days
Class 2
Risk

K821934 is an FDA 510(k) clearance for the BIO-CAL OPERATION CHECK KIT. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982 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 Bio-Analytics Laboratories, Inc. devices

Submission Details

510(k) Number K821934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1982
Decision Date July 20, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 94
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K821934.
PHOSPHOROUS STANDARD #65073
K822476 · Emd Chemicals, Inc. · Sep 1982
ACA URINARY PROTEIN CALIBRATOR
K822232 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1982
C-REACTIVE PROTEIN TEST KIT
K822332 · Sclavo, Inc. · Aug 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937 · Syva Co. · Jul 1982
SYVA ADVANCE STANDARDIZATION KIT #3
K821938 · Syva Co. · Jul 1982
BECKMAN URIC ACID STANDARD
K821813 · Beckman Instruments, Inc. · Jul 1982