Cleared Traditional

K992770 - QUALITROL IMMUNOLOGY CONTROL

K992770 is the FDA 510(k) clearance for QUALITROL IMMUNOLOGY CONTROL by Seracare Technology. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K992770 · Seracare Technology · Immunology device

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Nov 1999

Decision

87d

Days

Class 1

Risk

K992770 is an FDA 510(k) clearance for the QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Seracare Technology (Austin, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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: 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 Seracare Technology devices

Submission Details

510(k) Number	K992770 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 1999
Decision Date	November 12, 1999
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

17d faster than avg

Panel avg: 104d · This submission: 87d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JJY Multi-analyte Controls, All Kinds (assayed)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1660

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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 464

Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K992770.

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K992710 · Abbott Laboratories · Nov 1999

PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA

K992900 · Roche Diagnostics Corp. · Nov 1999

PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA

K993360 · Roche Diagnostics Corp. · Nov 1999

LYPHOCHEK ANEMIA CONTROL, MODEL 500

K992741 · Bio-Rad · Nov 1999

LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580

K992172 · Bio-Rad · Sep 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS

K992349 · Ortho-Clinical Diagnostics, Inc. · Aug 1999

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K992770

Seracare Technology

Austin, TX · US

RUSTY SEWELL

Regulatory profile

5 submissions 5 cleared

100% clearance rate · Active in Immunology

Data Intelligence Layer

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