510(k) Report

510(k) · Cleared

Cleared

Vitek Immunodiagnostic Assay System

K921302510(k) TraditionalCleared Jul 28, 1992131-day reviewClass II21 CFR 862.1155

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

Vitek Systems, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use

Cleared on Jul 28, 1992 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 28, 1992
Review
131 days
Class
Class II
Product code
JHI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared1990200020102020
  1. This deviceK921302 Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921302Vitek Immunodiagnostic Assay SystemVitek Systems, Inc.1992—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M…Biomerieux20154

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K921302, 1992–2015Source: 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 JHI? 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 JHI device

  1. #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 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 has not posted a summary or statement for it, 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
K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux20150

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, K141133 (Biomerieux, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JHI devices

JHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHI

1in 2024

2007: 42010: 12012: 22013: 22014: 22016: 12017: 12018: 12022: 12024: 12026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHI

101in 2007

2007: 101 days median
2007high 101 (2007)2026

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

Recalls per year · JHI

1in 2024

2007: 62008: 82009: 12010: 22011: 12023: 62024: 12026 (partial year): 4
2007high 8 (2008) · low 0 (2012)2026

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

Adverse event reports per year · JHI

265in 2025

2007: 2452008: 292009: 1062010: 1432011: 1382012: 2192013: 1852014: 1122015: 1342016: 1432017: 1132018: 1322019: 5712020: 1142021: 1582022: 1262023: 1472024: 2562025: 265
2007high 571 (2019) · low 29 (2008)2025

MAUDE reports naming product code JHI, 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
200741016245
20080—829
20090—1106
20101—2143
20110—1138
20122—0219
20132—0185
20142—0112
20150—0134
20161—0143
20171—0113
20181—0132
20190—0571
20200—0114
20210—0158
20221—0126
20230—6147
20241—1256
20250—0265
20261—4—

More from Vitek Systems, Inc.

39 FDA decisions under this applicant name. See the company

  • K920661Vidas CMV Igg AssayVitek Systems, Inc. · 19931 recall
  • K921176Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 19921 recall
  • K920952Vitek Immunodiag Assay Syst (Vidas) Ferritine AssayVitek Systems, Inc. · 1992
  • K915884Vidas Chlamydia Assay, ModificationVitek Systems, Inc. · 19921 recall
  • K905211Vidas Clostridium Difficile Toxin a (Cda) AssayVitek Systems, Inc. · 1991

Recent decisions in JHI

The JHI category page

  • K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026
  • K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2024
  • K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022
  • K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. · 2018
  • K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette…True Diagnostics, Inc. · 2017

https://510kreport.com/device/K921302 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921302: Vitek Immunodiagnostic Assay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921302

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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