The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling. For prescription use. Use with automated and semi-automated chemistry analyzers
Device Story
Multi-Analyte Chemistry Calibrator; lyophilized human serum with diluent; contains constituents for Albumin, Bilirubin, BUN, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Phosphorus, Total Protein, Triglycerides, and Uric Acid. Used in clinical laboratories to calibrate chemistry assays on automated/semi-automated analyzers. Values are lot-specific and provided in labeling. Human serum tested negative for HIV-1, HIV-2, HBsAg, and HCV. Provides standardized reference points for clinical chemistry testing; ensures accuracy of patient sample measurements.
Clinical Evidence
No clinical data. Bench testing only. Stability testing demonstrated 36-month shelf life at 2-8°C and 7-day open-vial stability (5 days for Bilirubin). Traceability established via NIST standard materials.
Technological Characteristics
Multi-analyte mixture; liquid or lyophilized form; intended for use with specific clinical chemistry analyzers as defined in product labeling. No specific materials or software algorithms described.
Indications for Use
Indicated for use as a calibrator for Pointe Scientific, Inc. clinical chemistry assays to establish set-point values for clinical laboratory testing.
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.
Submission Summary (Full Text)
{0}
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k070207
B. Purpose for Submission:
New device
C. Measurand:
None - Submission is for calibrators
D. Type of Test:
Calibrators
E. Applicant:
Pointe Scientific Inc.
F. Proprietary and Established Names:
Multi-Analyte Chemistry Calibrator
G. Regulatory Information:
1. Regulation section:
21 CFR§ 862.1150 – Calibrator
2. Classification:
Class II
3. Product code:
JIX – Calibrator, Multi-analyte mixture
4. Panel:
Clinical Chemistry (75)
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
3. Special conditions for use statement(s):
For prescription use.
4. Special instrument requirements:
Use with automated and semi-automated chemistry analyzers
I. Device Description:
{1}
The Multi-analyte Chemistry calibrator is a product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains calibrator constituents added to provide the defined assay values for Albumin, Total Bilirubin, Direct Bilirubin, BUN, Calcium, $\mathrm{CO}_{2}$, Chloride, Cholesterol, Creatinine, Glucose Hx, Glucose Ox, Iron, Magnesium, Phosphorus, Total Protein, Trig-GPO, and Uric Acid. The concentration of the calibrator components are lot specific and the values of the analytes are provided in the product labeling.
All human materials were tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HBsAg, and HCV.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Calibrator for Automated Systems
2. Predicate 510(k) number(s):
k990460
3. Comparison with predicates:
| Similarities | | |
| --- | --- | --- |
| Characteristics | Multi-Analyte Chemistry Calibrator (Proposed Device) | Roche Calibrator (C.f.a.s.) (Predicate Device) |
| Intended Use | The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling | For use as a calibrator of clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. |
| Composition | Lyophilized pooled serum with constituents added to obtain desired values | Lyophilized pooled serum with constituents added to obtain desired values |
| Stability | ●Unreconstituted chemistry calibrator is stable until the expiration date when stored at 2-8°C.
●Reconstituted chemistry calibrator is stable for seven days when stored at 2-8°C with the exception of Bilirubin, which is stable five days at 2-8°C.
●Store calibrator tightly capped and protected from light when not in use. | ●Stability of the lyophilized calibrator at 2-8°C: up to stated expiration date.
●Stability of the components in the reconstituted calibrator: at 2-8°C, 2 days. Exceptions: see below.
Total Bilirubin: at 2-8°C: 1 day.
Direct Bilirubin: at 2-8°C: 8 hours.
●Store calibrator tightly capped and protected from light when not in use. |
{2}
| Levels | Single Level | Single Level |
| --- | --- | --- |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, Total Bilirubin, Direct Bilirubin, BUN, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose Hx, Glucose Ox, Iron, Magnesium, Phosphorus, Total Protein, Trig-GPO, Uric Acid | Acid Phosphatase, Alkaline Phosphatase, Alanine Aminotransferase, Alpha-Amylase, Aspartate Aminotransferase, Cholinesterase, creatine kinase, Gamma-Glutamyl transferase, Lactate Dehydrogenase, Lipase, Albumin, Total Bilirubin, Direct Bilirubin, Urea (BUN), Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Phosphorus, Total Protein, Triglyceride, Uric Acid, Sodium, Potassium, Bicarbonate, UIBC, LDI |
# K. Standard/Guidance Document Referenced (if applicable):
Not Applicable
# L. Test Principle:
Not Applicable
# M. Performance Characteristics (if/when applicable): 3
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The sponsor provided the available NIST traceability information for constituents in the calibrator mixture. It is also available to the user upon request from the sponsor.
Value Assignment
The calibrator values are determined using Pointe Scientific, Inc. reagent methods and the analyzers listed in the value assignment table on the reverse side of the package insert. Determinations are performed under standardized conditions, utilizing known NIST standard materials. The commercial calibrator lot value is assigned with 3 runs, 10 values per run and using different lot numbers of the reagent. The final established value is obtained after calibrating against the previous calibrator lot, which is traceable to NIST
{3}
material at $100 \pm 10\%$. The sponsor’s final acceptance criterion is that the newly manufactured calibrator values must recover within $100 \pm 10\%$ of a previous lot of calibrator.
## Stability
The sponsor conducted long-term storage stability and open-vial stability using 3 lots and 3 replicates per lot. Data analysis demonstrated the products stored at +2 to +8°C are stable for at least 36 months. Testing cycles are, 0 and 36 months. Open-vial testing of reconstituted calibrator demonstrated 7-day stability for all the constituents with the exception of Bilirubin for which the data indicate stability of 5 days at +2 to +8°C storage.
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable
4. Clinical cut-off:
Not Applicable
5. Expected values/Reference range:
Not Applicable
## 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 a substantial equivalence decision.
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.
