510(k) Report

510(k) · Cleared

Cleared

Nichols Advantage Chemiluminescence Calcitonin Kit

K964635510(k) TraditionalCleared May 21, 1997183-day reviewClass II21 CFR 862.1140

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nichols Institute Diagnostics · JKR Radioimmunoassay, Calcitonin

Cleared on May 21, 1997 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
May 21, 1997
Review
183 days
Class
Class II
Product code
JKR
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964635 Nichols Advantage Chemiluminescence Calcitonin KitNichols Institute Diagnostics · 1997
  2. Descendant · cites it directly · 3 of its ownK023304 Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000…Diagnostic Products Corp. · 2002 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
  4. Descendant · 3 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
  5. Descendant · 3 generations on · 0 of its ownK182012 ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018

Most influential descendants

Showing 4 of 4 · See all
  • K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLDiagnostic Products Corp. · 2002 · cites it directly3descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 2 generations on2descendants
  • K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 3 generations on0descendants
  • K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964635Nichols Advantage Chemiluminescence Calcitonin KitNichols Institute Diagnostics1997—
+1K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin…Diagnostic Products Corp.20021
+2K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—
+3K252431Elecsys CalcitoninRoche Diagnostics GmbH2026—
+3K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201310
201810
202610
FIG. 1 — Lineage of K964635, 1997–2026Source: 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 JKR? 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 JKR device

  1. #1 K252431 Elecsys Calcitoninscore 13.9 · 10 generations · no Class I recall
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? (4)

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

NumberDeviceApplicantDecidedDescendants
K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLDiagnostic Products Corp.20023

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, K023304 (Diagnostic Products Corp., 2002) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JKR devices

JKR Radioimmunoassay, Calcitonin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKR

1in 2018

2013: 12018: 12026 (partial year): 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKR

Too few JKR 510(k)s in any year since 2007 to give a median.

Recalls per year · JKR

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKR

1in 2025

2009: 22010: 32012: 22014: 22016: 32017: 72018: 12019: 52020: 12021: 32022: 32024: 22025: 1
2007high 7 (2017) · low 0 (2007)2025

MAUDE reports naming product code JKR, 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
20070—00
20080—00
20090—02
20100—03
20110—00
20120—02
20131—00
20140—12
20150—00
20160—03
20170—07
20181—01
20190—05
20200—01
20210—03
20220—03
20230—00
20240—02
20250—01
20261—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 JKR

The JKR category page

  • K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026
  • K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited · 2018
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013
  • K060578Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)Scantibodies Laboratory, Inc. · 2006
  • K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLDiagnostic Products Corp. · 20021 recall

https://510kreport.com/device/K964635 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964635: Nichols Advantage Chemiluminescence Calcitonin Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964635

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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