CDC characterized serum proficiency panel; Archived clinical serum specimens from a university medical center
Retrospective analysis of a CDC proficiency panel and a comparative study of 300 previously collected clinical serum specimens to evaluate the performance of the IMMULITE Rubella IgG assay against a predicate device.
CDC characterized serum panel (82% positive, 18% negative); Number of Sites: 1 (DPC in-house)
CDC characterization
Total agreement with CDC results
University Medical Center Clinical Study; Retrospective study (previously collected and frozen specimens)
300 serum specimens from healthy individuals, pregnant women, and patients with miscellaneous conditions (AIDS, heart disease, etc.); Sample Size: 300; Number of Sites: 1
IMx Rubella IgG
Relative sensitivity and specificity
Indications for Use
IMMULITE Rubella IgG is designed for the qualitative detection of IgG antibodies to Rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella. This assay is particularly useful as an indicator of immune status for women of childbearing age.
Device Story
IMMULITE Rubella IgG is a solid-phase, two-step, chemiluminescent enzyme immunoassay used with the IMMULITE Automated Immunoassay Analyzer. Input: human serum sample. Process: sample and protein buffer incubated with rubella antigen-coated polystyrene beads; rubella IgG binds to antigen; centrifugal wash removes unbound serum; alkaline phosphatase-labeled anti-human IgG antibody added; second incubation and wash; chemiluminescent substrate (phosphate ester of adamantyl dioxetane) added; hydrolysis by alkaline phosphatase produces unstable intermediate emitting light. Output: photon output measured by luminometer, compared to established cutoff for qualitative result. Used in clinical laboratories to determine rubella immune status, aiding clinical decision-making for patient management, especially in pregnant women.
Clinical Evidence
Retrospective study using CDC proficiency panel (n=unknown) showed 98% total agreement (98% positive, 100% negative). Prospective clinical study at a university medical center (n=300) compared IMMULITE to IMx Rubella IgG. Subjects: 9 male, 291 female (ages 11-57). Results: 98.6% agreement; relative sensitivity 99.3% (95% CI: 97.4%-99.9%); relative specificity 91.3% (95% CI: 72.0%-98.9%).
Technological Characteristics
Solid-phase, two-step chemiluminescent enzyme immunoassay. Components: polystyrene bead coated with partially purified rubella antigen, alkaline phosphatase-labeled anti-human IgG antibody, phosphate ester of adamantyl dioxetane substrate. Automated system (IMMULITE Analyzer) performs incubation, centrifugal washing, and photon measurement. Qualitative result based on cutoff comparison.
Indications for Use
Indicated for qualitative detection of IgG antibodies to Rubella virus in human serum to determine immune status, particularly in women of childbearing age. Population includes males and females aged 11-57, including healthy individuals, pregnant women, and patients with miscellaneous conditions (AIDS, heart disease, immunocompromised, kidney transplant/dialysis).
Regulatory Classification
Identification
Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
{0}
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
Tel: (213) 776-0180
Fax: (213) 776-0204
K963613
APR -2 1997
# DPC
## 510 (k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045 |
| --- | --- |
| Telephone Number: | (213) 776-0180 |
| Facsimile Number: | (213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | January 20, 1997 |
| Device Name: | IMMULITE® Rubella IgG
LKRBZ (50 tests); LKRB2 (200 tests)
Reagent system for the determination of rubella IgG antibodies in human serum. |
| Trade: | Class III device (866.3510) |
| Catalog Number: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, California 90045 |
| Common: | |
| Classification: | #2017183 |
| Manufacturer: | Abbott Laboratories' IMx® Rubella IgG
K885297 |
| Establishment Registration #: | |
| Substantially Equivalent Predicate Device: | IMMULITE Rubella IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer |
| Description of Device: | IMMULITE Rubella IgG is designed for the qualitative detection of IgG antibodies to Rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella. This assay is particularly useful as an indicator of immune status for women of childbearing age. |
| Intended Use of the Device: | |
{1}
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: (213) 776-0180
Fax: (213) 776-0204
DPC®
## Summary and Explanation of the Device:
**IMMULITE® Rubella IgG** is a solid-phase, two-step, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with partially purified rubella antigen.
Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, rubella IgG in the sample binds to the rubella antigen-coated bead. Unbound serum is then removed by a centrifugal wash.
An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for an additional 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus the photon output, as measured by the luminometer - is directly related to the presence of rubella IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.
## Performance Equivalence - Technology Comparison:
Diagnostic Products Corporation (DPC) asserts that IMMULITE® Rubella IgG is substantially equivalent to the IMx® Rubella IgG kit marketed by Abbott Laboratories (Abbott Park, IL).
Each product is designed for the detection of IgG antibodies to rubella virus in human serum. Each product is intended strictly for *in vitro* diagnostic use as an aid in the determination of immune status to rubella.
**IMMULITE® Rubella IgG** is a chemiluminescent enzyme immunoassay, and IMx Rubella IgG is a microparticle enzyme immunoassay (MEIA). The technology in DPC's IMMULITE Rubella IgG is identical to technology used in previously cleared and commercially marketed IMMULITE® products.
In the IMx Rubella IgG assay, the patient sample and diluent buffer are added to predilution well of a reaction cell. Rubella virus coated microparticles and the diluted sample are added to an incubation well. The Rubella antibody binds to the Rubella virus coated microparticles, forming an antigen-antibody complex. Diluent buffer is added to the reaction mixture and an aliquot of the antigen-antibody complex is transferred to the glass fiber matrix. The microparticles bind irreversibly to the glass fiber matrix. The matrix is washed to remove unbound materials. The anti-human IgG/alkaline phosphatase conjugate is dispensed onto the matrix and binds to the antigen-antibody complex. Finally, the matrix is washed to remove unbound materials, the substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix, and the fluorescent product is measured by the optical assembly.
{2}
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: (213) 776-0180
Fax: (213) 776-0204
# Performance Equivalence - Clinical Performance:
The clinical performance of the IMMULITE Rubella IgG assay was studied at Diagnostic Products Corporation (DPC) using a Rubella proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC)
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Rubella IgG assay, and sending the results to the CDC for unmasking. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 82% positive and 18% negative samples. The IMMULITE Rubella IgG assay demonstrated 98% total agreement with the CDC results. Of the results obtained by DPC, there was 98% agreement with the positive specimens and 100% agreement with the negative specimens.
Studies on the clinical performance of the IMMULITE Rubella IgG assay were also conducted at a university medical center located in the northwestern United States. A total of 300 serum specimens (previously collected and frozen by the investigators) were tested. Of the 300 specimens used in the prospective clinical study, 31 were from healthy, asymptomatic individuals undergoing a pre-employment screening, 256 were from pregnant women undergoing rubella screening and the remainder were obtained from female patients with miscellaneous diseases and conditions (AIDS, heart disease, immunocompromised, kidney transplant/dialysis). There were 9 male and 291 female subjects, with ages ranging from 11 to 57 years.
All 300 specimens were evaluated with the IMMULITE Rubella IgG assay and the IMx Rubella IgG, an enzyme-linked fluorescent immunoassay (ELFA) which is commercially available on the IMx automated system.
## IMMULITE Rubella IgG
| IMx | Positive | Indeterminate | Negative | Relative Sensitivity | Relative Specificity |
| --- | --- | --- | --- | --- | --- |
| Positive | 271 | 1 | 2 | 99.3% | 91.3% |
| Indeterminate | 0 | 0 | 0 | | |
| Negative | 2 | 3 | 21 | | |
**Agreement:** 98.6%
**95% Confidence Limits for Relative Sensitivity and Specificity, respectively:**
97.4% - 99.9% and 72.0% - 98.9%
## Conclusion:
The conclusions drawn from the clinical and nonclinical studies demonstrate that the device is safe, effective, and performs as well as, or better, than the current legally marketed devices.
Edward M. Levine, Ph.D.
Director of Clinical Affairs
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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.
