510(k) · Cleared

Recalled · Class II · 2013

Fastpack Psa Immunoassay, Fastpack System

K994419510(k) TraditionalCleared Jun 28, 2000182-day reviewClass II21 CFR 866.6010Recalls 2

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

Qualisys Diagnostics, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Cleared on Jun 28, 2000 as substantially equivalent to P910007 (Abbott Laboratories, 1991) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1986. It has been recalled 2 times.

Decided: Jun 28, 2000
Review: 182 days
Class: Class II
Product code: LTJ
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K864319 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK864319 TDX (R) II AnalyzerAbbott Laboratories · 1986
This deviceK994419 Fastpack Psa Immunoassay, Fastpack SystemQualisys Diagnostics, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864319	TDX (R) II Analyzer	Abbott Laboratories	1986	—
0 (this device)	K994419	Fastpack Psa Immunoassay, Fastpack System	Qualisys Diagnostics, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K994419, 1986–2000Source: 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 LTJ? 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 LTJ device

#1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	P910007	Axsym Total Psa & Architect Total Psa Summary page 1 …ific Antigen (PSA). Photometer for clinical use. Classification Name: Prostatc-Specific Antigen (PSA) for Management of Prostate Cancer 3. Predicate Abbott IMX® PSA (P910007) using Abbott IMx® Analyzer (K864319) device 4. Device FastPack ™ PSA Immunoassay Reagents description The FastPack™ PSA Immuno…	Abbott Laboratories	1991	—
*	K864319	TDX (R) II Analyzer Summary page 1 …linical use. Classification Name: Prostatc-Specific Antigen (PSA) for Management of Prostate Cancer 3. Predicate Abbott IMX® PSA (P910007) using Abbott IMx® Analyzer (K864319) device 4. Device FastPack ™ PSA Immunoassay Reagents description The FastPack™ PSA Immunoassay is a two-sitec chemiluminescenc…	Abbott Laboratories	1986	—

Also cleared against P910007: 1 other device →

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
Nov 8, 2013	Class II	Z-0547-2014	Process change control	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Sep 29, 2008	Not classified	Z-0500-2009	Other	The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
1 other device also cites its predicate P910007.

How does its category compare?

All LTJ devices

LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTJ

3in 2025

2007high 10 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTJ

Too few LTJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LTJ

1in 2025

2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LTJ

14in 2025

2007high 109 (2011) · low 4 (2020)2025

MAUDE reports naming product code LTJ, 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	17
2008	0	—	3	57
2009	0	—	0	58
2010	0	—	2	34
2011	0	—	0	109
2012	0	—	0	101
2013	1	—	1	69
2014	0	—	0	19
2015	0	—	0	14
2016	2	—	0	8
2017	10	—	0	13
2018	7	—	0	8
2019	2	—	0	11
2020	1	—	0	4
2021	2	—	0	8
2022	0	—	0	11
2023	2	—	0	17
2024	3	—	0	8
2025	3	—	1	14
2026	3	—	0	—

What is it indicated for?

The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.

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/K994419 · printed Nov 5, 2026

Cite this page

510(k) Report. “K994419: Fastpack Psa Immunoassay, Fastpack System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994419

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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