510(k) · Cleared

Cleared

Liquichek Homocysteine Control, Cat #644

K984071510(k) TraditionalCleared Dec 3, 199817-day reviewClass I21 CFR 862.1660

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

Bio-Rad · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 3, 1998 as substantially equivalent to K980907 (Axis Biochemicals, Asa, 1998) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1998. 15 later devices descend from it.

Decided: Dec 3, 1998
Review: 17 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K980812 (1998). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK980812 Imx HomocysteineAxis Biochemicals, Asa · 1998
This deviceK984071 Liquichek Homocysteine Control, Cat #644Bio-Rad · 1998
Descendant · cites it directly · 14 of its ownK100715 Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010
Descendant · 2 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
Descendant · 3 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
Descendant · 3 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
Descendant · 3 generations on · 2 of its ownK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2010high 8 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 15 · See all

K100715Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010 · cites it directly14descendants
K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on13descendants
K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on7descendants
K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on3descendants
K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K980812	Imx Homocysteine	Axis Biochemicals, Asa	1998	—
0 (this device)	K984071	Liquichek Homocysteine Control, Cat #644	Bio-Rad	1998	—
+1	K100715	Audit Microcv Homocysteine Linearity Set, Model 704M-5	Aalto Scientific, Ltd.	2010	—
+2	K133128	Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…	Siemens Healthcare Diagnostics, Inc.	2013	—
+3	K140258	Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…	Siemens Healthcare Diagnostics, Inc.	2014	—
+3	K140818	Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…	Siemens Healthcare Diagnostics, Inc.	2014	—
+3	K140541	Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…	Siemens Healthcare Diagnostics, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0
2014	8	0
2015	5	0

FIG. 1 — Lineage of K984071, 1998–2015Source: 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 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

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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
*	K980907	Axis Homocysteine Enzyme Immunoassay Summary page 1 …erial o (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Axis Homocysteine EIA Control Kit Axjs Biochemicals ASA, P.O. Box 206 Okemn, Oslo K980907, K980812 Statement of Intended Use Liquichek Homocysteine Control is intended for use as an assayed quality control serum to mon…	Axis Biochemicals, Asa	1998	—
*	K980812	Imx Homocysteine Summary page 1 …Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Axis Homocysteine EIA Control Kit Axjs Biochemicals ASA, P.O. Box 206 Okemn, Oslo K980907, K980812 Statement of Intended Use Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the…	Axis Biochemicals, Asa	1998	—

Also cleared against K980907: 2 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K100715	Audit Microcv Homocysteine Linearity Set, Model 704M-5	Aalto Scientific, Ltd.	2010	14

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?

None of the 2 ancestors has a recall.
Of its descendants, K100715 (Aalto Scientific, Ltd., 2010) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K980907.

How does its category compare?

All JJX devices

JJX 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

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)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?

Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

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/K984071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984071: Liquichek Homocysteine Control, Cat #644.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984071

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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