510(k) · Cleared
ClearedBesure Plus One-Step Home Ovulation Predictor Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntron Bioresearch, Inc. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on Nov 18, 1998 as substantially equivalent to K951538 (Syntron Bioresearch, Inc., 1995) after a 75-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Nov 18, 1998
- Review
- 75 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951538 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951538 Besure One-=Step Home Ovulation Predictor KitSyntron Bioresearch, Inc. · 1995
- This deviceK983113 Besure Plus One-Step Home Ovulation Predictor KitSyntron Bioresearch, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK994035 Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951538 | Besure One-=Step Home Ovulation Predictor Kit | Syntron Bioresearch, Inc. | 1995 | — |
| 0 (this device) | K983113 | Besure Plus One-Step Home Ovulation Predictor Kit | Syntron Bioresearch, Inc. | 1998 | — |
| +1 | K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Diagnostic Chemicals, Ltd. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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 CEP? 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
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 |
|---|---|---|---|
| * | K951538 | Besure One-=Step Home Ovulation Predictor KitSummary page 1…n test. The exact differences in reagent between the two protocols are as follows: BeSure Plus OneStep BeSure OneStep Ovulation Predictor Test Ovulation Predictor Test (K951538) Specimen Volume Midstream 4 drops of urine Reagent No Reagent No Reagent Incubation 5 minutes 5 minutes Steps 1 Step 1 Step Sur… | 1995 |
| † | K871602 | Microcheck LH Ovulation Test | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | 2000 | 0 |
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.
- Of its descendants, K994035 (Diagnostic Chemicals, Ltd., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CEP devicesCEP Radioimmunoassay, Luteinizing Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEP
FDA has decided no CEP device since 2007.
Median 510(k) review, days · CEP
Too few CEP 510(k)s in any year since 2007 to give a median.
Recalls per year · CEP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEP
1in 2023
MAUDE reports naming product code CEP, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983113 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983113: Besure Plus One-Step Home Ovulation Predictor Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983113
Report an extraction error
Are you the manufacturer?
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