510(k) Report

510(k) · Cleared

Cleared

Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056

K001411510(k) TraditionalCleared Aug 21, 2000109-day reviewClass II21 CFR 862.1545

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

Scantibodies Laboratory, Inc. · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Aug 21, 2000 after a 109-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 21, 2000
Review
109 days
Class
Class II
Product code
CEW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared2019: 1 descendant cleared200020052010201520202025
  1. This deviceK001411 Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay…Scantibodies Laboratory, Inc. · 2000
  2. 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
  3. Descendant · 2 generations on · 0 of its ownK190702 Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc. · 2015 · cites it directly1descendant
  • K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001411Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model…Scantibodies Laboratory, Inc.2000—
+1K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH…DiaSorin, Inc.20151
+2K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201910
FIG. 1 — Lineage of K001411, 2000–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CEW? 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 CEW device

  1. #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 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? (2)

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

NumberDeviceApplicantDecidedDescendants
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?

  • Of its descendants, K150879 (DiaSorin, Inc., 2015) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CEW devices

CEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEW

2in 2024

2007: 42010: 12012: 12013: 22014: 12015: 12017: 22019: 12023: 12024: 2
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEW

160in 2007

2007: 160 days median
2007high 160 (2007)2026

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

Recalls per year · CEW

1in 2025

2007: 12008: 12010: 32013: 12016: 22022: 22024: 22025: 1
2007high 3 (2010) · low 0 (2009)2026

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

Adverse event reports per year · CEW

37in 2025

2008: 82009: 42010: 232011: 972012: 1242013: 1722014: 1672015: 572016: 982017: 832018: 652019: 772020: 502021: 572022: 1882023: 822024: 672025: 37
2007high 188 (2022) · low 0 (2007)2025

MAUDE reports naming product code CEW, 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
2007416010
20080—18
20090—04
20101—323
20110—097
20121—0124
20132—1172
20141—0167
20151—057
20160—298
20172—083
20180—065
20191—077
20200—050
20210—057
20220—2188
20231—082
20242—267
20250—137
20260—0—

More from Scantibodies Laboratory, Inc.

19 FDA decisions under this applicant name. See the company

  • K060578Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)Scantibodies Laboratory, Inc. · 2006
  • K060420Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3KG002Scantibodies Laboratory, Inc. · 2006
  • K060348Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay KitScantibodies Laboratory, Inc. · 2006
  • K051888Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013Scantibodies Laboratory, Inc. · 2005
  • K051810Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014Scantibodies Laboratory, Inc. · 2005

Recent decisions in CEW

The CEW category page

  • K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics · 2024
  • K232791Access Intact PTHBeckman Coulter, Inc. · 20241 recall
  • K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics · 2023
  • K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019
  • K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K001411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001411: Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001411

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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