510(k) Report

510(k) · Cleared

Cleared

Thyroid Peroxidase Auto Antibodies (Tpo) Immun Kit

K931311510(k) TraditionalCleared May 14, 199360-day reviewClass II21 CFR 866.5870

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

Nichols Institute · JZO System, Test, Thyroid Autoantibody

Cleared on May 14, 1993 after a 60-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
May 14, 1993
Review
60 days
Class
Class II
Product code
JZO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK931311 Thyroid Peroxidase Auto Antibodies (Tpo) Immun KitNichols Institute · 1993
  2. Descendant · cites it directly · 0 of its ownK982866 Nichols Advantage Chemiluminescence Thyroid Peroxidase…Nichols Institute Diagnostics · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K982866Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay, Model…Nichols Institute Diagnostics · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931311Thyroid Peroxidase Auto Antibodies (Tpo) Immun KitNichols Institute1993—
+1K982866Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies…Nichols Institute Diagnostics1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K931311, 1993–1998Source: 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 JZO? 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 JZO device

  1. #1 K250250 ADVIA Centaur Anti-Thyroid Peroxidase IIscore 10.5 · 2 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
K982866Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay, Model…Nichols Institute Diagnostics19980

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, K982866 (Nichols Institute Diagnostics, 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JZO devices

JZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JZO

1in 2025

2008: 22009: 22010: 12016: 22020: 12023: 22024: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JZO

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

Recalls per year · JZO

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · JZO

44in 2025

2010: 12011: 52012: 42013: 42014: 22015: 42016: 82017: 122018: 352019: 392020: 172021: 192022: 252023: 332024: 292025: 44
2007high 44 (2025) · low 0 (2007)2025

MAUDE reports naming product code JZO, 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
20082—00
20092—00
20101—01
20110—05
20120—04
20130—04
20140—02
20150—04
20162—08
20170—012
20180—035
20190—039
20201—017
20210—019
20220—025
20232—033
20241—029
20251—144
20260—0—

More from Nichols Institute

15 FDA decisions under this applicant name. See the company

  • K952559Erythropoietin Immunoassay KitNichols Institute · 1996
  • K952505Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)Nichols Institute · 1995
  • K946247Igfbp-3; Insulin-Like Growth Factor Binding Protein-3Nichols Institute · 1995
  • K950524Nichols Institute Diagnostics Dhea-S Chemiluminescence ImmunoassayNichols Institute · 1995
  • K932650Erythropoietin Immunoassay KitNichols Institute · 1994

Recent decisions in JZO

The JZO category page

  • K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc. · 2025
  • K240469Access TPO AntibodyBeckman Coulter, Inc. · 2024
  • K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc. · 2023
  • K222610Elecsys Anti-TgRoche Diagnostics · 2023
  • K193313Elecsys Anti-TSHRRoche Diagnostics · 20201 recall

https://510kreport.com/device/K931311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931311: Thyroid Peroxidase Auto Antibodies (Tpo) Immun Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931311

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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