510(k) Report

510(k) · Cleared

Recalled · 2007

Elecsys Parathyroid Hormone Test System

K992680510(k) TraditionalCleared Sep 28, 199949-day reviewClass II21 CFR 862.1545Recalls 1

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

Roche Diagnostics Corp. · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Sep 28, 1999 as substantially equivalent to K954418 (Nichols Institute Diagnostics, 1995) after a 49-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it. It has been recalled once.

Decided
Sep 28, 1999
Review
49 days
Class
Class II
Product code
CEW
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K954418 (1995). 11 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2006: 1 descendant cleared2024: 2 descendants cleared2013: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant clearedK954418 · Intact Parathyroid Hormone (PTH) Immunoassay (Modification) · Nichols Institute Diagnostics · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K954418 · Intact Parathyroid Hormone (PTH) Immunoassay (Modification) · Nichols Institute Diagnostics · 19950
  1. Root · 1 generation backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
  2. This deviceK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999
  3. Descendant · cites it directly · 3 of its ownK063232 Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low…Biokit, S.A. · 2007 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK121981 Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013 · Recalled
  5. Descendant · cites it directly · 2 of its ownK070709 Roche Elecsys PTH Test SystemRoche Diagnostics Corp. · 2007
  6. Descendant · 3 generations on · 1 of its ownK133601 Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014
  7. Descendant · cites it directly · 1 of its ownK061190 Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc. · 2006 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006: 12007: 42013: 12014: 12017: 12023: 12024: 2
2006high 4 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all
  • K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High)…Biokit, S.A. · 2007 · cites it directly3descendants
  • K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics · 2013 · 2 generations on2descendants
  • K070709Roche Elecsys PTH Test SystemRoche Diagnostics Corp. · 2007 · cites it directly2descendants
  • K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on1descendant
  • K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc. · 2006 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954418Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics1995—
0 (this device)K992680Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp.1999—
+1K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium…Biokit, S.A.20074
+2K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics20132
+1K070709Roche Elecsys PTH Test SystemRoche Diagnostics Corp.2007—
+3K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc.2014—
+1K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200740
201310
201410
201710
202310
202420
FIG. 1 — Lineage of K992680, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K954418Intact Parathyroid Hormone (PTH) Immunoassay (Modification)
Summary page 1
…t to other device Device Name Device description devices legally marketed in the United States. We claim equivalence to the Nichols RIA test for Parathyroid Hormone (K954418). Proprietary name: ELECSYS® Parathyroid Hormone Test System Common name: Parathyroid Hormone Test Classification name: Radioim…
Nichols Institute Diagnostics1995—

Also cleared against K954418: 1 other device →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High)…Biokit, S.A.20073
K070709Roche Elecsys PTH Test SystemRoche Diagnostics Corp.20072
K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc.20061
K063605ST Aia-Pack Intact PTH AssayTosoh Bioscience, Inc.20070
K070391Elecsys PTH Test SystemRoche Diagnostics Corp.20070

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 19, 2007Not classifiedZ-0810-2007OtherNegative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K063232 (Biokit, S.A., 2007) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K954418.

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?

For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for 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.

Also cleared against K954418

1 other device cites the same predicate.

  • K020217Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 20024 recalls

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

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/K992680 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992680: Elecsys Parathyroid Hormone Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992680

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026