510(k) Report

510(k) · Cleared

Cleared

Liaison N-Tact PTH Calibration Verifiers Model 310913

K093498510(k) TraditionalCleared Dec 14, 200932-day reviewClass I21 CFR 862.1660

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

DiaSorin, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 14, 2009 as substantially equivalent to K033426 (DiaSorin, Inc., 2004) after a 32-day review. Its family tree reaches back 1 generation to 2004. 7 later devices descend from it.

Decided
Dec 14, 2009
Review
32 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K033426 (2004). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 2 descendants cleared2022: 1 descendant clearedK033426 · Liaison N-Tact PTH · DiaSorin, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K033426 · Liaison N-Tact PTH · DiaSorin, Inc. · 20040
  1. Root · 1 generation backK033426 Liaison N-Tact PTHDiaSorin, Inc. · 2004
  2. This deviceK093498 Liaison N-Tact PTH Calibration Verifiers Model 310913DiaSorin, Inc. · 2009
  3. Descendant · cites it directly · 4 of its ownK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
  4. Descendant · 2 generations on · 3 of its ownK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
  5. Descendant · 3 generations on · 1 of its ownK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
  6. Descendant · cites it directly · 1 of its ownK150879 LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH…DiaSorin, Inc. · 2015 · Recalled
  7. Descendant · 4 generations on · 0 of its ownK213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12018: 22019: 12022: 1
2013high 2 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013 · cites it directly4descendants
  • K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014 · 2 generations on3descendants
  • K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc. · 2018 · 3 generations on1descendant
  • K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc. · 2015 · cites it directly1descendant
  • K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033426Liaison N-Tact PTHDiaSorin, Inc.2004—
0 (this device)K093498Liaison N-Tact PTH Calibration Verifiers Model 310913DiaSorin, Inc.2009—
+1K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc.2013—
+2K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc.2014—
+3K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin…DiaSorin, Inc.2018—
+1K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH…DiaSorin, Inc.20151
+4K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.20221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201820
201910
202210
FIG. 1 — Lineage of K093498, 2004–2022Source: 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 JJX? 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
Get a 510(k) Report

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
*K033426Liaison N-Tact PTH
Summary page 1
…JJX PREDICATE DEVICES: LIAISON® N-TACT® PTH Control Set Reference K033426 DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers are assayed quality control materials i…
DiaSorin, Inc.2004—

Also cleared against K033426: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc.20134
K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc.20151

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, K132515 (DiaSorin, Inc., 2013) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K033426.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

The DiaSorin LIAISON® N-TACT® Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Assay when performed on the LIAISON® Analyzer.

Indications for use as stated in the FDA summary.

Also cleared against K033426

2 other devices cite the same predicate.

  • K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc. · 20151 recall
  • K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013

More from DiaSorin, Inc.

444 FDA decisions under this applicant name. See the company

  • P180047/S046LIAISON® QuantiFERON®-TB Gold Plus II.DiaSorin, Inc. · 2026
  • P180047/S045LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus…DiaSorin, Inc. · 2026
  • P180047/S043LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold…DiaSorin, Inc. · 2026
  • P220034/S010LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026
  • P220034/S011LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026

Recent decisions in JJX

The JJX category page

  • K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K093498 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093498: Liaison N-Tact PTH Calibration Verifiers Model 310913.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093498

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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