510(k) · Cleared

Recalled · Class II · 2016

Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers

K063720510(k) TraditionalCleared Apr 9, 2007115-day reviewClass II21 CFR 862.1155Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortho-Clinical Diagnostics · DHA System, Test, Human Chorionic Gonadotropin

Cleared on Apr 9, 2007 as substantially equivalent to K983424 (Abbott Laboratories, 1998) and 2 other predicates after a 115-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.

Decided: Apr 9, 2007
Review: 115 days
Class: Class II
Product code: DHA
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K970894 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970894 Vitros Immunodiagnostics Products Total B-HCG Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
This deviceK063720 Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack…Ortho-Clinical Diagnostics · 2007
Descendant · cites it directly · 0 of its ownK233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024

Most influential descendants

Showing 1 of 1 · See all

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970894	Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
0 (this device)	K063720	Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators…	Ortho-Clinical Diagnostics	2007	—
+1	K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack	Ortho Clinical Diagnostics	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K063720, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K983424	Abbott Archeitect Total B-HCG Summary page 2 …VITROS Imnimunodiagnostic Products Total [- hCG II Range Verifiers are substantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total j3-HCG assay (K983424) and VITROS Immunodiagnostic Products Total [-hCG Range Verifiers (K970894). 5 Device Description The VITROS Immunodi…	Abbott Laboratories	1998	—
*	K970894	Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG… Summary page 2 …tantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total j3-HCG assay (K983424) and VITROS Immunodiagnostic Products Total [-hCG Range Verifiers (K970894). 5 Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and sem…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
*	K973517	Vitros Immunodiagnostic Products Range Verifiers Summary page 3 …lly equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total 13-HCG assay (K983424) assay and VITROS Immunodiagnostic Products Total 3-hCG Range Verifiers (K973517). Tables I through 4 compare the VITROS Immunodiagnostic Products Total f3- hCG II assay and Range Verifiers to the Abbot…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—

Also cleared against K983424: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack	Ortho Clinical Diagnostics	2024	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 18, 2016	Class II	Z-1700-2016	Under Investigation by firm	When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient…

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K233581 (Ortho Clinical Diagnostics, 2024) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K983424.

How does its category compare?

All DHA devices

DHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DHA

1in 2024

2007high 3 (2021) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHA

63in 2023

2007high 289 (2021) · low 63 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DHA

2in 2022

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DHA

234in 2025

2007high 478 (2011) · low 52 (2015)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?

For quantitative measurement of human chorionic gonadotropin (hCG) and its n-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.

For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its [-subunit in human serum and plasma (EDTA or heparin).

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its [-subunit.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063720 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063720

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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