# K020217: Acs:180 and Advia Centaur Ipth Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Mar 15, 2002 after 52 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954418 (1995). 1 ancestor in all.
12 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954418: Intact Parathyroid Hormone (PTH) Immunoassay (Modification), Nichols Institute Diagnostics (1995) Summary page 1.

## Most influential descendants
- K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra (2013), 5 descendants of its own
- K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers (2013), 4 descendants of its own
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers (2014), 3 descendants of its own
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own
- K182698: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (2018), 1 descendant of its own

## Recalls of this device
- Aug 16, 2013 · Class III · Z-0173-2014: PTH Calibrator packaged with only high calibrator.
- May 14, 2013 · Class II · Z-1514-2013: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
- May 14, 2013 · Class II · Z-1515-2013: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
- Oct 3, 2008 · Not classified · Z-1186-2012: Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

## Indications for use
The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated ACS:180 and ADVIA Centaur analyzers marketed by Bayer Corporation. Intact PTH levels can be used to aide in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

Source page: https://510kreport.com/device/K020217
Methodology: https://510kreport.com/methodology