510(k) Report

510(k) · Cleared

Cleared

Immulite TSH Third Generation Control

K930007510(k) TraditionalCleared Aug 16, 1993224-day reviewClass I21 CFR 862.1660

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

Diagnostic Products Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Aug 16, 1993 after a 224-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
Aug 16, 1993
Review
224 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1997: 1 descendant cleared1996: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK930007 Immulite TSH Third Generation ControlDiagnostic Products Corp. · 1993
  2. Descendant · cites it directly · 2 of its ownK960195 Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK990658 Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc. · 1999
  4. Descendant · 2 generations on · 0 of its ownK030912 Thyro TestThryotec · 2003 · Recalled
  5. Descendant · cites it directly · 0 of its ownK963916 Immulite CannabinoidsDiagnostic Products Corp. · 1997

Most influential descendants

Showing 4 of 4 · See all
  • K960195Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc. · 1996 · cites it directly2descendants
  • K990658Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc. · 1999 · cites it directly1descendant
  • K030912Thyro TestThryotec · 2003 · 2 generations on0descendants
  • K963916Immulite CannabinoidsDiagnostic Products Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930007Immulite TSH Third Generation ControlDiagnostic Products Corp.1993—
+1K960195Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc.1996—
+1K990658Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc.1999—
+2K030912Thyro TestThryotec20031
+1K963916Immulite CannabinoidsDiagnostic Products Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910
200310
FIG. 1 — Lineage of K930007, 1993–2003Source: 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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)

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

NumberDeviceApplicantDecidedDescendants
K960195Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc.19962
K990658Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc.19991
K963916Immulite CannabinoidsDiagnostic Products Corp.19970

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, K960195 (Franklin Diagnostics, Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K930007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930007: Immulite TSH Third Generation Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930007

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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