510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500 Tests), L2KPP2 (200 Tests), L2KPP6

K013566510(k) SpecialCleared Nov 20, 200125-day reviewClass II21 CFR 862.1545Recalls 3

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 Nov 20, 2001 as substantially equivalent to K011505 (Diagnostic Products Corp., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 3 times.

Decided
Nov 20, 2001
Review
25 days
Class
Class II
Product code
CEW
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K011505 (2001). No later device cites it as a predicate yet.

K011505 · Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6 · Diagnostic Products Corp. · 200120002002
K011505 · Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6 · Diagnostic Products Corp. · 20010
  1. Root · 1 generation backK011505 Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests)…Diagnostic Products Corp. · 2001
  2. This deviceK013566 Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100…Diagnostic Products Corp. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011505Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000…Diagnostic Products Corp.2001—
0 (this device)K013566Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5…Diagnostic Products Corp.2001—
FIG. 1 — Lineage of K013566, 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), 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K011505Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact…
Summary page 2
…ngeles, California 90045-5597 13 Establishment Registration Number: DPC’s Registration Number is 2017183 Substantially Equivalent IMMULITE Intact PTH (K011505) Predicate Device: IMMULITE 2000 Intact PTH (K011505) IMMULITE Intact PTH and IMMULITE 2000 Intact PTH are solid phase, chemilum…
Diagnostic Products Corp.2001—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 22, 2025Class IIZ-0366-2026Under Investigation by firmThe potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE…
Nov 22, 2016Class IIZ-0979-2017Under Investigation by firmSiemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE 2000/IMMULITE 2000 XPi Intact PTH kit lot 320 can exhibit an…
Feb 23, 2004Not classifiedZ-0724-04OtherHigh bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

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—

What is it indicated for?

The IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH assays are for in vitro diagnostic use with their respective analyzers for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K013566 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013566: Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500 Tests), L2KPP2 (200 Tests), L2KPP6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013566

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026