510(k) · Cleared
ClearedBiosafe Cholesterol Profile Blood Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosafe Laboratories, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Sep 26, 2001 as substantially equivalent to K934046 (Beckman-Diagnostic Systems Group, 1993) and 2 other predicates after a 93-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Sep 26, 2001
- Review
- 93 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781939 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781939 Reagent Kit, TriglyceridesBeckman Instruments, Inc. · 1979
- This deviceK011970 Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781939 | Reagent Kit, Triglycerides | Beckman Instruments, Inc. | 1979 | — |
| 0 (this device) | K011970 | Biosafe Cholesterol Profile Blood Collection and Transport System | Biosafe Laboratories, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 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? (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 |
|---|---|---|---|
| * | K934046 | Beckman Cholesterol Reagent Our OCR of the scanned summary read K974046, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Beckman Synchron Synchron CX Systems Cholesterol (CHOL) Reagent”. | 1993 |
| * | K972041 | EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5)Summary page 1…sterol (21 CFR 862.1475) Total Cholesterol Beckman Synchron Synchron CX Systems Cholesterol (CHOL) Reagent (K974046) HDL Cholesterol Sigma EZ HDL™ Cholesterol Reagent (K972041) Triglycerides Beckman Triglycerides Reagent Kit (K781939) The device is a kit containing the materials necessary to collect a… | 1997 |
| * | K781939 | Reagent Kit, TriglyceridesSummary page 1…n Synchron CX Systems Cholesterol (CHOL) Reagent (K974046) HDL Cholesterol Sigma EZ HDL™ Cholesterol Reagent (K972041) Triglycerides Beckman Triglycerides Reagent Kit (K781939) The device is a kit containing the materials necessary to collect a capillary blood sample onto a filter paper card for transpo… | 1979 |
| † | K903015 | Synermed Cholesterol Reagent Kit | 1990 |
| † | K844032 | Triglyceride Reagent | 1984 |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K934046.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.
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/K011970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011970: Biosafe Cholesterol Profile Blood Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011970
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026