510(k) Report

510(k) · Cleared

Cleared

Hycor HY.Tec/Manual SS-a Auto-Antibody

K962719510(k) TraditionalCleared Mar 7, 1997249-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

Hycor Biomedical, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control

Cleared on Mar 7, 1997 after a 249-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 7, 1997
Review
249 days
Class
Class II
Product code
LLL
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962719 Hycor HY.Tec/Manual SS-a Auto-AntibodyHycor Biomedical, Inc. · 1997
  2. Descendant · cites it directly · 3 of its ownK141328 Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60…Inova Diagnostics, Inc. · 2015
  3. Descendant · 2 generations on · 0 of its ownK253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
  4. Descendant · 2 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  5. Descendant · 2 generations on · 0 of its ownK210902 EliA Ro52, EliA Ro60Phadia AB · 2022

Most influential descendants

Showing 4 of 4 · See all
  • K141328Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsInova Diagnostics, Inc. · 2015 · cites it directly3descendants
  • K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026 · 2 generations on0descendants
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · 2 generations on0descendants
  • K210902EliA Ro52, EliA Ro60Phadia AB · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962719Hycor HY.Tec/Manual SS-a Auto-AntibodyHycor Biomedical, Inc.1997—
+1K141328Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsInova Diagnostics, Inc.2015—
+2K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited2026—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.2023—
+2K210902EliA Ro52, EliA Ro60Phadia AB2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202210
202310
202610
FIG. 1 — Lineage of K962719, 1997–2026Source: 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), 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. #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. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141328Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsInova Diagnostics, Inc.20153

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?

  • Of its descendants, K141328 (Inova Diagnostics, Inc., 2015) has gone furthest, with 3 descendants of its own.

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.

FDA decisions per year · LLL

2in 2025

2008: 12010: 12011: 12013: 22015: 32016: 22018: 12019: 12023: 12025: 22026 (partial year): 2
2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLL

265in 2015

2015: 265 days median
2007high 265 (2015)2026

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

Recalls per year · LLL

1in 2012

2008: 12011: 12012: 1
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

2011: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—10
20090—00
20101—00
20111—11
20120—10
20132—00
20140—00
2015326500
20162—00
20170—00
20181—00
20191—00
20200—00
20210—00
20220—00
20231—00
20240—00
20252—00
20262—0—

More from Hycor Biomedical, Inc.

51 FDA decisions under this applicant name. See the company

  • K081217HY-Tec Specific and Total Ige Eia SystemHycor Biomedical, Inc. · 20081 recall
  • K080322HY*Tec Extended Specific Ige Eia, MCS Assay Using Tecan Freedom Evo RSP 200Hycor Biomedical, Inc. · 2008
  • K022945Autostat II Anti-B-2 Glycoprotein I Igg ElisaHycor Biomedical, Inc. · 2002
  • K022944Autostat II Anti-B-2 Glycoprotein-I Igm ElisaHycor Biomedical, Inc. · 2002
  • K965094Hycor Allergen DiscHycor Biomedical, Inc. · 1997

Recent decisions in LLL

The LLL category page

  • K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
  • K253367EliA CTD 13 ScreenPhadia AB · 2026
  • K250666Alegria Flash CTD ScreenZeus Scientific · 2025
  • K250408Alegria Flash ENA ScreenZeus Scientific · 2025
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023

https://510kreport.com/device/K962719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962719: Hycor HY.Tec/Manual SS-a Auto-Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962719

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026