510(k) Report

510(k) · Cleared

Cleared

Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit

K962598510(k) TraditionalCleared Dec 10, 1996161-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

Nichols Institute Diagnostics · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Dec 10, 1996 after a 161-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Dec 10, 1996
Review
161 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 2004: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962598 Nichols Advantage Chemiluminescence Intact Parathyroid Hormone KitNichols Institute Diagnostics · 1996
  2. Descendant · cites it directly · 0 of its ownK040813 Nichols Advantage Chemiluminescence Intact Parathyroid Hormone…Nichols Institute Diagnostics · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K040813Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022Nichols Institute Diagnostics · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962598Nichols Advantage Chemiluminescence Intact Parathyroid Hormone KitNichols Institute Diagnostics1996—
+1K040813Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022Nichols Institute Diagnostics2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K962598, 1996–2004Source: 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 lists a 510(k) statement for it but has not posted the file, 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
K040813Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022Nichols Institute Diagnostics20040

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, K040813 (Nichols Institute Diagnostics, 2004) 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 Nichols Institute Diagnostics

68 FDA decisions under this applicant name. See the company

  • K050784Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2005
  • K042676Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) AssayNichols Institute Diagnostics · 20041 recall
  • K042689Nichols Advantage CortisolNichols Institute Diagnostics · 2004
  • K040813Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022Nichols Institute Diagnostics · 2004
  • K033727Nichols Advantage Bio-Intact PTH (1-84) ImmunoassayNichols Institute Diagnostics · 20041 recall

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/K962598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962598: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962598

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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