510(k) · Cleared
Recalled · Class II · 2024Pregnancy-Skreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochemical Diagnostic, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Mar 29, 2005 as substantially equivalent to K965171 (Bio-Rad, 1997) and 2 other predicates after a 48-day review. Its family tree reaches back 4 generations to 1989. It has been recalled 2 times.
- Decided
- Mar 29, 2005
- Review
- 48 days
- Class
- Class I
- Product code
- JJX
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890577 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- 3 generations backK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- 2 generations backK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- 1 generation backK042446 Quantify Control and Quantify Plus ControlsBio-Rad Laboratories, Inc. · 2004
- This deviceK050328 Pregnancy-SkreenBiochemical Diagnostic, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| −3 | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426) | Bio-Rad | 1997 | — |
| −2 | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control… | Bio-Rad | 2003 | — |
| −1 | K042446 | Quantify Control and Quantify Plus Controls | Bio-Rad Laboratories, Inc. | 2004 | — |
| 0 (this device) | K050328 | Pregnancy-Skreen | Biochemical Diagnostic, Inc. | 2005 | — |
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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Summary page 2…TM We conducted a comparison study of the performance of Biochemical Diagnostics' Pregnancy-Skreen positive and negative controls with the Biorad Liquichek (k965171, k031231) and qUAntity urine controls. (k042446). The Biorad products are multi-constituent whereas Biochemical Diagnostics' cont… | 1997 |
| * | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…Summary page 2…TM We conducted a comparison study of the performance of Biochemical Diagnostics' Pregnancy-Skreen positive and negative controls with the Biorad Liquichek (k965171, k031231) and qUAntity urine controls. (k042446). The Biorad products are multi-constituent whereas Biochemical Diagnostics' control is a… | 2003 |
| * | K042446 | Quantify Control and Quantify Plus ControlsSummary page 2…of the performance of Biochemical Diagnostics' Pregnancy-Skreen positive and negative controls with the Biorad Liquichek (k965171, k031231) and qUAntity urine controls. (k042446). The Biorad products are multi-constituent whereas Biochemical Diagnostics' control is a single constituent product designed to… | 2004 |
| † | K971886 | Accutest HCG-Urine | 1997 |
| † | K972748 | Cards Q.S. HCG-Urine; and Concise Performance Plus HCG-Urine | 1997 |
| † | K020799 | Quickvue One-Step HCG-Urine | 2002 |
| † | K925586 | Detectabuse (TM) | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2024 | Class II | Z-1312-2024 | Storage | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60… |
| Sep 14, 2015 | Class III | Z-0328-2016 | Labeling False and Misleading | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K965171.
How does its category compare?
All JJX devicesJJX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Biochemical Diagnostics, Inc., Pregnancy-Skreen urine controls are intended to validate the performance of qualitative hCG methods. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used by health care professionals as an integral part of good laboratory practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050328: Pregnancy-Skreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050328
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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