Cleared Traditional

K990843 - SERUM CROSSLAPS ONE STEP ELISA

K990843 is an FDA 510(k) clearance for SERUM CROSSLAPS ONE STEP ELISA, manufactured by Osteometer Biotech A/S. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K990843 · Osteometer Biotech A/S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
116d
Days
Class 1
Risk

K990843 is an FDA 510(k) clearance for the SERUM CROSSLAPS ONE STEP ELISA. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Osteometer Biotech A/S (Herlev, DK). The FDA issued a Cleared decision on July 9, 1999 after a review of 116 days - within the typical 510(k) review window.

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 Osteometer Biotech A/S devices

FDA 510(k) Submission Details - K990843

510(k) Number K990843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date July 09, 1999
Days to Decision 116 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
28d slower than avg
Panel avg: 88d · This submission: 116d
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 15
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K990843.
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · Roche Diagnostics Corp. · Jul 2000
OSTEOMARK NTX POC
K992997 · Metrika, Inc. · Nov 1999
OSTEOMARK NTX SERUM EIA
K983457 · Ostex Intl., Inc. · Feb 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
K983674 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
CROSSLAPS ELISA
K972788 · Devices and Diagnostics Consulting Group · Dec 1998
PYRILINKS-D ASSAY KIT
K981364 · Metra Biosystems, Inc. · Aug 1998