510(k) Report

510(k) · Cleared

Cleared

Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6

K011505510(k) TraditionalCleared Jul 2, 200147-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

Diagnostic Products Corp. · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Jul 2, 2001 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 2, 2001
Review
47 days
Class
Class II
Product code
CEW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared200020052010201520202025
  1. This deviceK011505 Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests)…Diagnostic Products Corp. · 2001
  2. Descendant · cites it directly · 0 of its ownK013566 Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100…Diagnostic Products Corp. · 2001 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K013566Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500…Diagnostic Products Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011505Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000…Diagnostic Products Corp.2001—
+1K013566Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5…Diagnostic Products Corp.20013

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K011505, 2001–2001Source: 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 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K013566Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500…Diagnostic Products Corp.20010

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, K013566 (Diagnostic Products Corp., 2001) has gone furthest, with 0 descendants 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 Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

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/K011505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011505: Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011505

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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