510(k) Report

510(k) · Cleared

Cleared

Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls

K141655510(k) TraditionalCleared Mar 5, 2015258-day reviewClass II21 CFR 866.5100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inova Diagnostics, Inc. · OBE Anti-Ss-A 52 Autoantibodies

Cleared on Mar 5, 2015 as substantially equivalent to K063565 (Inova Diagnostics, Inc., 2007) after a 258-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.

Decided
Mar 5, 2015
Review
258 days
Class
Class II
Product code
OBE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K063565 (2007). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared2022: 1 descendant clearedK063565 · Quanta Lite SS-a 52 Elisa · Inova Diagnostics, Inc. · 200720052010201520202025
Descendants, by generation 1 generation forward: 2 descendants K063565 · Quanta Lite SS-a 52 Elisa · Inova Diagnostics, Inc. · 20070
  1. Root · 1 generation backK063565 Quanta Lite SS-a 52 ElisaInova Diagnostics, Inc. · 2007
  2. This deviceK141655 Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash…Inova Diagnostics, Inc. · 2015
  3. Descendant · cites it directly · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  4. Descendant · cites it directly · 0 of its ownK210902 EliA Ro52, EliA Ro60Phadia AB · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · cites it directly0descendants
  • K210902EliA Ro52, EliA Ro60Phadia AB · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K063565Quanta Lite SS-a 52 ElisaInova Diagnostics, Inc.2007—
0 (this device)K141655Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsInova Diagnostics, Inc.2015—
+1K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.2023—
+1K210902EliA Ro52, EliA Ro60Phadia AB2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
FIG. 1 — Lineage of K141655, 2007–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K063565Quanta Lite SS-a 52 Elisa
Summary page 6
…Regulation Number 862.1660 Device Class 1 (reserved) Predicate device: QUANTA Lite® SS-A 52 ELISA, 510(k) number: K063565 Device description The QUANTA Flash Ro52 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automa…
Inova Diagnostics, Inc.2007—

Also cleared against K063565: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230
K210902EliA Ro52, EliA Ro60Phadia AB20220

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K213403 (Inova Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K063565.

How does its category compare?

All OBE devices

OBE Anti-Ss-A 52 Autoantibodies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OBE

1in 2015

2007: 12015: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBE

Too few OBE 510(k)s in any year since 2007 to give a median.

Recalls per year · OBE

No recall names OBE since 2007.

Adverse event reports per year · OBE

No MAUDE report names OBE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—

What is it indicated for?

QUANTA Flash Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Sjögren’s Syndrome, Systemic Sclerosis, Idiopathic Inflammatory Myopathies. QUANTA Flash Ro52 Controls are intended for use with the QUANTA Flash Ro52…

Read the full statement (118 words)

QUANTA Flash Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Sjögren’s Syndrome, Systemic Sclerosis, Idiopathic Inflammatory Myopathies.

QUANTA Flash Ro52 Controls are intended for use with the QUANTA Flash Ro52 Reagents for quality control in the determination of IgG anti-Ro52 autoantibodies in human serum.

QUANTA Flash Ro52 Calibrators are intended for use with the QUANTA Flash Ro52 Reagents for the determination of IgG anti-Ro52 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

Indications for use as stated in the FDA summary.

Also cleared against K063565

1 other device cites the same predicate.

  • K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US · 2014

More from Inova Diagnostics, Inc.

138 FDA decisions under this applicant name. See the company

  • K243979Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021

Recent decisions in OBE

The OBE category page

  • K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBZeus Scientific · 2026
  • K063565Quanta Lite SS-a 52 ElisaInova Diagnostics, Inc. · 2007

https://510kreport.com/device/K141655 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141655

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026