Cleared Traditional

K980638 - ADI SYPHILIS RPR LIQUID CONTROLS

K980638 is an FDA 510(k) clearance for ADI SYPHILIS RPR LIQUID CONTROLS, manufactured by Ampcor Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GMP cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K980638 · Ampcor Diagnostics, Inc. · Microbiology device
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Jul 1998
Decision
137d
Days
Class 2
Risk

K980638 is an FDA 510(k) clearance for the ADI SYPHILIS RPR LIQUID CONTROLS. Classified as Antisera, Control For Nontreponemal Tests (product code GMP), Class II - Special Controls.

Submitted by Ampcor Diagnostics, Inc. (Bridgeport, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K980638

510(k) Number K980638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date July 06, 1998
Days to Decision 137 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 102d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMP Device Classification - Class 2, Special Controls

Product Code GMP Antisera, Control For Nontreponemal Tests
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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 Microbiology devices follow this clearance model.

Regulatory Peers - GMP Antisera, Control For Nontreponemal Tests

All 8
Devices cleared under the same product code (GMP) and FDA review panel - the closest regulatory comparables to K980638.
QUALITROL SYPHSERO CONTROL SET
K961998 · Consolidated Technologies, Inc. · Aug 1996
RPR LIQUID CONTROLS
K955143 · Remel, L.P. · Jul 1996
VISUWELL REAGIN TEST 960 TEST KIT
K885298 · Allelix Diagnostics, Inc. · Mar 1989
V-TREND RPRL CARD TEST
K875180 · Texas Immunology, Inc. · Feb 1988
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · Ncs Diagnostics, Inc. · Aug 1985
RPR TEST REDITEST
K843741 · Biokit USA, Inc. · Oct 1984
K980638 · ADI SYPHILIS RPR LIQUID CONTROLS
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