510(k) · Cleared
Clearedi-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Apr 16, 2015 as substantially equivalent to K983424 (Abbott Laboratories, 1998) and 1 other predicate after a 569-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Apr 16, 2015
- Review
- 569 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022232 (2002). 3 ancestors in all, the oldest K983424 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK022232 Cliniqa Liquid-QC HCG Control Level 1, 2, and 3Cliniqa Corporation · 2002
- 1 generation backK121237 Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control…Cliniqa Corporation · 2012
- This deviceK133002 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT…Abbott Point of Care, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022232 | Cliniqa Liquid-QC HCG Control Level 1, 2, and 3 | Cliniqa Corporation | 2002 | — |
| −1 | K121237 | Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3… | Cliniqa Corporation | 2012 | — |
| 0 (this device) | K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total… | Abbott Point of Care, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983424 | Abbott Archeitect Total B-HCGSummary page 5…U.S.A. 3. Predicate Device Predicate Device Name: Abbott ARCHITECT System Total β-hCG Predicate 510(k) Number: k983424 Regulation Number: Class II (regulation number 862.1155) Classification Product Code: DHA Pred… | 1998 |
| * | K121237 | Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…Summary page 5…ber 862.1155) Classification Product Code: DHA Predicate Device Name: Cliniqa Beta HCG Control Level 1, 2, 3 Predicate 510(k) Number: k121237 Regulation Description: Quality Control Material (Assayed and Unassayed) Classification: Class 1 (regulat… | 2012 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K983424.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The i-STAT® Total Beta-Human Chorionic Gonadotropin (β-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of β-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
The i-STAT® Total β-hCG Controls are used to monitor performance of the i-STAT Total β-hCG test.
The i-STAT® Total β-hCG Calibration Verification Materials are used to verify the calibration of the i-STAT Total β-hCG test throughout the reportable range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133002: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133002
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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