Cleared Traditional

K972788 - CROSSLAPS ELISA

K972788 is an FDA 510(k) clearance for CROSSLAPS ELISA, manufactured by Devices and Diagnostics Consulting Group. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K972788 · Devices and Diagnostics Consulting Group · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
512d
Days
Class 1
Risk

K972788 is an FDA 510(k) clearance for the CROSSLAPS ELISA. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Devices and Diagnostics Consulting Group (Rockville, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

FDA 510(k) Submission Details - K972788

510(k) Number K972788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date December 22, 1998
Days to Decision 512 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
424d slower than avg
Panel avg: 88d · This submission: 512d
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 20
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K972788.
SERUM CROSSLAPS ONE STEP ELISA
K990843 · Osteometer Biotech A/S · Jul 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
PYRILINKS-D ASSAY KIT
K981364 · Metra Biosystems, Inc. · Aug 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · Diagnostic Products Corp. · May 1998
OSTEOMARK
K980518 · Ostex Intl., Inc. · Mar 1998
K972788 · CROSSLAPS ELISA
Download PDF FDA Summary Devices and Diagnosti…