K051928 · Radiometer Medical Aps · JJY · Oct 12, 2005 · Clinical Chemistry
Device Facts
Record ID
K051928
Device Name
AUTOCHECK6+
Applicant
Radiometer Medical Aps
Product Code
JJY · Clinical Chemistry
Decision Date
Oct 12, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1660
Device Class
Class 1
Indications for Use
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood gases, co-oximetry, electrolytes, bilirubin, glucose, lactate, and creatinine.
Device Story
AutoCheck6+ is a liquid quality control system consisting of four levels of aqueous solutions packaged in ampoules. It is used to verify the precision and accuracy of Radiometer Medical ApS analyzers. The system contains components for pH, blood gases, co-oximetry, electrolytes, bilirubin, glucose, lactate, and creatinine. It includes added creatine, creatinine, and the enzyme creatininase to stabilize the equilibrium between creatine and creatinine. The device is used in clinical laboratory settings where Radiometer analyzers are operated by trained personnel. By measuring these control solutions, clinicians assess the performance of the analyzer to ensure reliable patient test results.
Clinical Evidence
No clinical data. Bench testing only. Stability established via real-time and accelerated studies (storage at 6°C, 10°C, 25°C, 32°C, and 40°C). Traceability to NIST SRM 914 for creatinine and other chemistry standards for remaining parameters.
Technological Characteristics
Liquid quality control system consisting of four levels of aqueous solutions. Contains pH/blood gas, co-oximetry, electrolyte, bilirubin, glucose, lactate, and creatinine components. Includes creatininase (creatinine amidohydrolase) for stabilization. Analyzed using standard Radiometer analyzer measurement protocols.
Indications for Use
Indicated for use as a quality control material to verify the precision and accuracy of Radiometer Medical ApS analyzers measuring pH, blood gases, co-oximetry, electrolytes, bilirubin, glucose, lactate, and creatinine.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
AutoCheck5+ (part of K992859 - ABL7000 with AutoCheck Module)
Submission Summary (Full Text)
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1
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k051928
B. Purpose for Submission:
New device (control)
C. Measurand:
Control for pH/Blood gases, co-oximetry, electrolytes, glucose, lactate and creatinine
D. Type of Test:
Control material
E. Applicant:
Radiometer Medical ApS
F. Proprietary and Established Names:
AutoCheck6+
G. Regulatory Information:
1. Regulation section:
21 CFR Section 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product code:
JJY, control, Multi-analyte mixture
4. Panel:
Chemistry (75)
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H. Intended Use:
1. Intended use(s):
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood gases, co-oximetry, electrolytes, bilirubin, glucose, lactate, and creatinine.
2. Indication(s) for use:
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood gases, co-oximetry, electrolytes, bilirubin, glucose, lactate, and creatinine.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
For use with Radiometer analyzers
I. Device Description:
The AutoCheck6+ quality control system includes control material at four different levels (Levels 1-4). The controls are aqueous and consist of a buffer with salts, metabolites, enzymes, dyes and preservatives, equilibrated with carbon dioxide and oxygen. The controls do not contain any animal or biological components.
The controls are supplied in 0.7 mL ampoules, 30 ampoules per box of each control level. The ampoules are used only once after being opened.
J. Substantial Equivalence Information:
1. Predicate device name(s):
AutoCheck5+
2. Predicate 510(k) number(s):
k992859
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3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | AutoCheck6+ | AutoCheck5+ |
| Intended use | same | For use in checking the precision and accuracy of Radiometer analyzers. |
| Format | same | Liquid control contained in ampoules. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Test parameters | pH, pCO2, pO2, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHbF, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, ctBil and the addition of cCrea (creatinine) | pH, pCO2, pO2, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHbF, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, ctBil |
K. Standard/Guidance Document Referenced (if applicable):
N/A
L. Test Principle:
N/A
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability: The different parameters contained within AutoCheck6+ are traceable to various chemistry standards, with most parameters traceable to a NIST SRM. A Certificate of Traceability was provided for each level of control. The added parameter, creatinine, is traceable to NIST SRM 914.
The control ranges are determined by using an established protocol that includes performing runs on six different analyzers and with several different operators over a number of days. The final ranges for each level of the control are lot specific and found on the Control Ranges data sheets provided with the product. Additionally, the controls can only be used on the Radiometer analyzers listed on the data sheets.
Stability: The stability of the closed ampoules was established using both real-time and accelerated stability studies. Only closed container stability was performed since the control is used only one time after the ampoule is opened. Since the stability in the labeling is stated to be 24 months at 2-8°C, 4 weeks at up to 25°C, or 15 days for up to 32°C, several different stability studies are performed. These included storage at 6°C, 10°C, and 25°C for 103 weeks as well as storage at 32°C and 40°C for 39 weeks and 26 weeks respectively. Upon testing at the various time points, the measured results must fall within the preset acceptable performance limits for each parameter.
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A
2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A
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3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a. and b. are not applicable):
N/A
4. Clinical cut-off:
N/A
5. Expected values/Reference range:
N/A
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports substantial equivalence decision.
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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
