510(k) · Cleared
ClearedInstant-View LH Ovulation Predicting Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on Nov 5, 2002 as substantially equivalent to K981271 (Unipath, Ltd., 1998) after a 71-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 5, 2002
- Review
- 71 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981271 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981271 Clearplan Easy Ovulation TestUnipath, Ltd. · 1998
- This deviceK022829 Instant-View LH Ovulation Predicting TestAlfa Scientific Designs, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981271 | Clearplan Easy Ovulation Test | Unipath, Ltd. | 1998 | — |
| 0 (this device) | K022829 | Instant-View LH Ovulation Predicting Test | Alfa Scientific Designs, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K981271 | Clearplan Easy Ovulation TestSummary page 1…of Summary Preparation October 9, 2002 Predicate Device CLEARPLAN EasyTM One-Step Ovulation Predictor (K98 1271) Device Description This test is a one-step lateral flow chromatographic immunoassay.… | 1998 |
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.
- 4 other devices also cite its predicate K981271.
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?
The Instant-View TM LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. It is for health care professional use, including at the point of care (physician’s office labs, doctor’s offices) .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022829: Instant-View LH Ovulation Predicting Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022829
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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