DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.
Device Story
Aqueous liquid calibrator containing ammonia, ethanol, and lactate; used in clinical chemistry laboratories to calibrate automated, semi-automated, or manual analyzers. Provides lot-specific set point values for quantitative determination of analytes. Used by laboratory technicians to ensure accuracy of patient sample measurements. Benefits patient by ensuring reliable, standardized clinical chemistry results for ammonia, ethanol, and lactate.
Clinical Evidence
Bench testing only. Method comparison study performed per NCCLS EP9 protocol comparing quantitative analytical recovery of patient samples using subject calibrator versus predicate calibrators on Hitachi 717 and Beckman Synchron CX5 systems. Results indicate subject device behaves similarly to predicates and is suitable for intended use.
Technological Characteristics
Aqueous matrix calibrator; single level; contains ammonia, ethanol, and lactate; packaged in plastic containers with dropper tips. Stability: 30 days open. Traceable/Assigned values for analytes.
Indications for Use
Indicated for in vitro diagnostic use as a calibrator for automated, semi-automated, or manual clinical chemistry systems measuring ammonia, ethanol, and lactate levels in patient samples.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
New England Reagent Laboratories Ammonia Standards (K962629)
{0}
SEP 13 1996
K962629
Exhibit 21. 510(k) Summary
FEDERAL FOOD, DRUG AND COSMETIC ACT
510(k) SUMMARY
DOCUMENT® Ammonia, Ethanol, Lactate Calibrator, Levels I, II, III
1. Submitted by: CASCO Standards
P.O. Box 970
Yarmouth, ME 04096
Attention: Christine V. Beach
Manager, Regulatory Affairs
(207) 878-7550
(207) 878-7578 FAX
2. Product Name:
Proprietary Name: DOCUMENT® Ammonia, Ethanol, Lactate Calibrator
Classification Name: Control, multiple analyte, assayed.
Page • 125 •
{1}
K962629
3. Predicate Device:
Analyte: Ammonia
Manufacturer: Boehringer Mannheim Corp., Indianapolis, IN
System: Hitachi 717 System
Reagents: Boehringer Mannheim Corp., Ammonia, Kit No. 450055
Calibrator: New England Reagent Laboratories, East Providence, RI
Ammonia Standards, 100μmol/L, part of Kit No. NERL 1207
Analyte: Ethanol
Manufacturer: Beckman Instruments, Brea, CA
System: Beckman Synchron CX5
Reagents: Beckman Instruments, Alcohol, Kit No: 445900
Calibrator: Beckman Instruments, Fullerton, CA
Alcohol, part of Kit No. 445900
Analyte: Lactate
Manufacturer: Beckman Instruments, Brea, CA
System: Beckman Synchron CX5
Reagents: Beckman Instruments, Lactate, Kit No. 445875
Calibrator: Beckman Instruments, Fullerton, CA
Lactate, CX Multi Calibrator, Part No. 442600
4. Product Description:
DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol, and lactate. The formulation design provides a liquid calibrator intended for use on automated, semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).
5. Intended Use:
DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.
Page • 126 •
{2}
K962629
6. Comparison to the Predicate Device:
| Characteristic | DOCUMENT®
Ammonia, Ethanol, Lactate Calibrator | New England Reagent Laboratory Ammonia Standards | Beckman Alcohol Kit Calibrator | Beckman CX Multi Calibrator |
| --- | --- | --- | --- | --- |
| Intended Use | Intended for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. | None given | Intended for the quantitative determination of alcohol concentration in serum or plasma on SYNCHRON CX Systems | Intended for use on the SYNCHRON CX Systems for the calibration of ..., Lactate, ... |
| Number of Levels | One | Five | One | One |
| Type | Traceable: Ammonia Ethanol Assigned: Lactate | Assigned | Assigned | Assigned |
| Analytes | 3 | 1 | 1 | Many |
| Volume | 4 mL | 5 mL | 5 mL | 20 mL |
| Matrix | Aqueous | Aqueous | Aqueous | Human serum, Liquid |
| Dilution | None required | None required | None required | None required |
| Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date |
| Open Stability | 30 Days | None indicated | 7 Days | 20 Days |
| Container | Plastic, Dropper Tip | Plastic, Dropper Tip | Plastic, Dropper Tip | Plastic, Dropper Tip |
Page • 127 •
{3}
K962629
## 7. Test Results:
The equivalence for this product was carried out by comparing quantitative analytical recovery of patient samples using the NCCLS EP9 Protocol: *Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline*. The DOCUMENT Ammonia, Ethanol, Lactate Calibrator was compared to the NERL 100μmol/L Ammonia Standard using BMC Ammonia reagents on a Hitachi 717 Clinical Chemistry Analyzer, the Beckman Alcohol Kit Calibrator with Beckman Reagents on a Beckman Synchron CX5 System, and the Beckman CX Multi Calibrator using Beckman Lactate reagent on a Beckman Synchron CX5 System. The results show that the DOCUMENT Ammonia, Ethanol, Lactate Calibrator behaves in a similar manner compared to the predicate devices and is suitable for use as a calibrator for the listed analytes on those systems tested.
Page • 128 •
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
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.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
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.
6. Collections
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.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
8. Chart view
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.
