510(k) · Cleared

Cleared

Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls

K141210510(k) TraditionalCleared Jan 29, 2015265-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. · LLL Extractable Antinuclear Antibody, Antigen And Control

Cleared on Jan 29, 2015 as substantially equivalent to K922832 (Inova Diagnostics, Inc., 1992) after a 265-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.

Decided: Jan 29, 2015
Review: 265 days
Class: Class II
Product code: LLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922832 (1992). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK922832 Quanta Lite SS-B ElisaInova Diagnostics, Inc. · 1992
This deviceK141210 Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash…Inova Diagnostics, Inc. · 2015
Descendant · cites it directly · 0 of its ownK253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
Descendant · cites it directly · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026 · cites it directly0descendants
K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922832	Quanta Lite SS-B Elisa	Inova Diagnostics, Inc.	1992	—
0 (this device)	K141210	Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls	Inova Diagnostics, Inc.	2015	—
+1	K253817	IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La	Immunodiagnostics Systems Limited	2026	—
+1	K213403	Aptiva CTD Essential Reagent	Inova Diagnostics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2026	1	0

FIG. 1 — Lineage of K141210, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Top candidate predicates for a new LLL device

#1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K922832	Quanta Lite SS-B Elisa Summary page 6 …JJX Regulation Number 862.1660 Device Class 1 (reserved) Predicate device: QUANTA Lite® SS-B ELISA, 510(k) number: K922832 Device description The QUANTA Flash SS-B assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automa…	Inova Diagnostics, Inc.	1992	—

Also cleared against K922832: 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.

Number	Device	Applicant	Decided	Descendants
K253817	IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La	Immunodiagnostics Systems Limited	2026	0
K213403	Aptiva CTD Essential Reagent	Inova Diagnostics, Inc.	2023	0

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, K253817 (Immunodiagnostics Systems Limited, 2026) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K922832.

How does its category compare?

All LLL devices

LLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LLL

2in 2025

2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLL

265in 2015

2007high 265 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLL

1in 2012

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLL

1in 2011

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code LLL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	1	—	1	0
2009	0	—	0	0
2010	1	—	0	0
2011	1	—	1	1
2012	0	—	1	0
2013	2	—	0	0
2014	0	—	0	0
2015	3	265	0	0
2016	2	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	0	0
2024	0	—	0	0
2025	2	—	0	0
2026	2	—	0	—

What is it indicated for?

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

Read the full statement (114 words)

laboratory tests is an aid in the diagnosis of Sjögren’s Syndrome and Systemic Lupus Erythematosus.

QUANTA Flash SS-B Calibrators are intended for use with the QUANTA Flash SS-B Reagents for the determination of

IgG anti-SS-B autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that

is used to calculate unit values.

QUANTA Flash SS-B Controls are intended for use with the QUANTA Flash SS-B reagents for quality control in the

determination of IgG anti-SS-B autoantibodies in human serum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141210: Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141210

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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