Cleared Traditional

K841464 - CHANGES IN THE CHEMICAL COMP. OF 5

K841464 is an FDA 510(k) clearance for CHANGES IN THE CHEMICAL COMP. OF 5, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K841464 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
102d
Days
Class 2
Risk

K841464 is an FDA 510(k) clearance for the CHANGES IN THE CHEMICAL COMP. OF 5. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 102 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 Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K841464

510(k) Number K841464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date June 22, 1984
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 269
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K841464.
SERACON TM SR IV
K844026 · Bhp Diagnostix, Inc. · Nov 1984
SERACON TM SR III
K844027 · Bhp Diagnostix, Inc. · Nov 1984
DOUMENT TM LINEARITY TEST STANDARDS
K843947 · Casco Standards · Oct 1984
SODIUM & POTASSIUM STANDARD SOLUT
K841419 · Reagent Laboratory, Inc. · May 1984
SODIUM & POTASSIUM STANDARD SOL 80
K841420 · Reagent Laboratory, Inc. · May 1984
TRIGLYCERIDE/CHOLESTEROL AQUEOUS
K840219 · Preventive Diagnostics Corp. · Mar 1984