510(k) · Cleared
ClearedLacrytest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adiatec SA · DGC Ige, Antigen, Antiserum, Control
Cleared on Mar 9, 2004 as substantially equivalent to K964152 (Pharmacia, Inc., 1997) after a 70-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 9, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- DGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964152 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964152 Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHPharmacia, Inc. · 1997
- This deviceK034057 LacrytestAdiatec SA · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH | Pharmacia, Inc. | 1997 | — |
| 0 (this device) | K034057 | Lacrytest | Adiatec SA | 2004 | — |
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 DGC? 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 DGC device
- #1 K231151 Kenota 1 Total IgE; Kenota 1 (instrument)score 8.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHSummary page 1…NTIGEN, ANTISERUM, CONTROL Regulation Number 866.5510 510(K) Number K964152 Device Name UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL I… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K964152.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DGC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DGC
Too few DGC 510(k)s in any year since 2007 to give a median.
Recalls per year · DGC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DGC
2in 2021
MAUDE reports naming product code DGC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Lacrytest is a rapid immunoassay for the detection of total IgE in tears. Semi-quantitative detection of total IgE in tears (< 2.5 klU/Iiter, 2.5 - 10 klU,qiter, 10 - 40 klU/liter, and > 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034057: Lacrytest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034057
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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