# K013566: Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500 Tests), L2KPP2 (200 Tests), L2KPP6

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Nov 20, 2001 after 25 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011505 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011505: Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6, Diagnostic Products Corp. (2001) Summary page 2.

## Recalls of this device
- Sep 22, 2025 · Class II · Z-0366-2026: The 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
- Nov 22, 2016 · Class II · Z-0979-2017: Siemens 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 I
- Feb 23, 2004 · Not classified · Z-0724-04: High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

## Indications for use
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.

Source page: https://510kreport.com/device/K013566
Methodology: https://510kreport.com/methodology