Cleared Traditional

K994438 - BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

K994438 is an FDA 510(k) clearance for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER, manufactured by Spectrx, Inc.. The device is a Class 1 Chemistry device with product code MQM cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K994438 · Spectrx, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
36d
Days
Class 1
Risk

K994438 is an FDA 510(k) clearance for the BILICHEK NON-INVASIVE BILIRUBIN ANALYZER. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Spectrx, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1113 - 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 Spectrx, Inc. devices

FDA 510(k) Submission Details - K994438

510(k) Number K994438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date February 04, 2000
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

MQM Device Classification - Class 1, General Controls

Product Code MQM Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1113
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 - MQM Bilirubin (total And Unbound) In The Neonate Test System

All 11
Devices cleared under the same product code (MQM) and FDA review panel - the closest regulatory comparables to K994438.
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · Siemens Healthcare Diagnostics · Aug 2011
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · Roche Diagnostics Corp. · May 2004
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · Respironics, Inc. · Mar 2001
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · Respironics, Inc. · Mar 1999
NBIL
K983134 · Abbott Laboratories · Sep 1998
JM-102 JAUNDICE METER
K972309 · Air-Shields, Inc. · Sep 1998