Cleared Traditional

K993706 - ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

K993706 is an FDA 510(k) clearance for ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY, manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K993706 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
265d
Days
Class 1
Risk

K993706 is an FDA 510(k) clearance for the ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 24, 2000 after a review of 265 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1400 - 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K993706

510(k) Number K993706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1999
Decision Date July 24, 2000
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 88d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

JMM Device Classification - Class 1, General Controls

Product Code JMM Column Chromatography & Color Development, Hydroxyproline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMM Column Chromatography & Color Development, Hydroxyproline

All 8
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K993706.
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
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