The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state. PRECAUTION: The POCkit™ HSV-2 Rapid Test is intended for use in a high prevalence population, e.g. sexually active adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use. The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population e.g. prenatal patients, on immunocompromised individuals, for prenatal or neonatal screening, on other patients with HSV associated diseases, or for early stages of HSV seroconversion.
Device Story
POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for detecting IgG antibodies to HSV-2. Input: capillary whole blood (fingerstick) or serum. Principle: membrane-based immunoassay using specific antibody binding protein conjugated to colloidal gold particles and semi-purified HSV-2 glycoprotein G2 antigen. Test window contains a TEST spot (HSV-2 antigen) and a CONTROL spot (human IgG). When sample passes through membrane, anti-HSV-2 antibodies bind to TEST spot; developing reagent reacts with human IgG to produce pink/red color at both spots. Used at point-of-care by health professionals. Output: visual color change indicating presence of antibodies. Assists clinicians in diagnosing previous HSV-2 infection; does not distinguish between latent or active states. Benefits patient by providing rapid serological assessment in high-prevalence clinical settings.
Clinical Evidence
Clinical evaluation included 1193 whole blood samples and 1220 serum samples. Performance was evaluated relative to the HSV-2 Western Blot method. The CDC serum panel for HSV-2 serology was also tested. No specific sensitivity/specificity percentages or p-values were provided in the summary text.
Technological Characteristics
Membrane-based qualitative immunoassay. Components: solid phase membrane, wicking material, plastic housing. Reagents: antibody binding protein conjugated to colloidal gold, semi-purified HSV-2 glycoprotein G2 antigen, human IgG control. Manual, point-of-care test. No electronic components or software.
Indications for Use
Indicated for qualitative detection of IgG antibodies to HSV-2 in heparinized capillary whole blood or serum. Intended for use by health professionals in high-prevalence settings (e.g., STD clinics). Not for general population screening, prenatal, pediatric, neonatal, or immunocompromised populations. Not for medical/legal use.
Regulatory Classification
Identification
Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
Special Controls
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Predicate Devices
Gull HSV-2 IgG ELISA test
Reference Devices
Western Blot HSV Type 2
Submission Summary (Full Text)
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8/19/99
K983886
# 510(k) SUMMARY
The assigned 510(k) number is: K983888
Applicant Informațion:
| Date Prepared: | February 20, 1999 |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Submitter's Name: | Diagnology Limited<br>Unit 5 Kennedy Enterprise Center<br>Blackstaff Road<br>Belfast, BT11 9DT U.K. |
| Contact Organization: | Schiff & Company, Inc. |
|-----------------------|------------------------|
| Contact Person: | Dr. Robert Schiff |
| Phone Number: | 973-227-1830 |
| Fax Number: | 973-227-5330 |
Device Information:
| Trade Name: | POCkit™ HSV-2 Rapid Test |
|----------------------|---------------------------------------------------|
| Common Name: | Herpes simplex virus Type 2 Antibody Test |
| Classification Name: | In vitro Diagnostic to detect antibodies to HSV-2 |
# Equivalent Device Description:
The device was found equivalent to Gull HSV-2 IgG ELISA test. Comparative testing was performed with Western Blot HSV Type 2.
# Device Description:
The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum.
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### Device Intended Use:
The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoasaay The Founlitative determination, either in heparinized capillary whole blood taken lor the qualifiate acterim. of circulating IgG antibodies specific for herpes by inigerstick of in acturity of chocking to a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous tesung. The processes of may be of value in determination of previous Intection with PISV-2 and may bo of value in Seconsis of HSV associated disease. Immunological experience the to whether infection is currently in a latent or active state.
#### PRECAUTION:
The POCkit™ HSV-2 Rapid Test is intended for use in a high provalence ITHE FOOK! - 1109-2 hope've adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use.
The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population . . . prenatal patlents, on immunocompromised individuals, for prenatal or nonatal screening, on other patients with HSV associated diseases, or for sarly stages of HŠV seroconversion.
### Principle of the Procedure:
The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window.
When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human
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p.8
IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit.
### Performance Data:
The POCklt™ HSV-2 Rapid Test was evaluated relative to the HSV-2 Western Blot method. In addition, the CDC serum panel for HSV-2 serology assays was tested with this device.
A total of 1193 whole blood samples and 1220 serum samples were evaluated. These results are shown in the tables 1,2 and 3 below.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three stripes above it, symbolizing health and human services. The text "DEPT. OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 9 1999
bragnology Ltd. Dr. Robert Schiff c/o Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
K983886 Re: Trade Name: POCkit™ HSV-2 Rapid Test Regulatory Class: III Product Code: LGC Dated: June 4, 1999 Received: June 7, 1999
# Dear Dr. Schiff:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your bootion by o(x) ce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate use stated in the eneround, to regard the enactment date of the Medical Device Amendments, commence proof to May 20, 1976, ais editor with the provisions of the Federal For to devices mat nave been ot (Act). You may, therefore, market the device, subject to the I ood, Drug, and Cosmitons of the Act. The general controls provisions of the Act include general controls for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major (1 remarket / tpproval), it ins / see can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Furrent Good Manufacturing Practice requirements, as set forth in the Quality System Ourchil Good Manical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such through performs QB inspections).ith the GMP regulation may result in regulatory action. In assumptions. I andre to compts here announcements concerning your device in the Federal addition, I Dri may packist response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Dage 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### INDICATIONS FOR USE STATEMENT
510(K) NUMBER: K983886
DEVICE NAME: POCkit™ HSV-2 Rapid Test
## Indications for Use:
The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state.
#### PRECAUTION:
:
The POCkit™ HSV-2 Rapid Test is intended for use in a high prevalence population, e.g. sexually active adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use.
The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population e.g. prenatal patients, on Immunocompromised individuals, for prenatal or neonatal screening, on other patients with HSV associated diseases, or for early stages of HSV seroconversion.
Woody Dubois
icinn Sion. ivision of Clin 510(k) Number
OR
Prescription Use (Per 21 CFR 801.109) Over-The Counter Use
(Optional Format 1-2-96)
ﻠﺴ
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.
