(303 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a skin testing applicator, with no mention of AI or ML capabilities.
No
The device is used for the "percutaneous administration of diagnostic allergenic extracts," indicating its purpose is for diagnosis (allergy testing), not therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "for the percutaneous administration of diagnostic allergenic extracts." This explicitly indicates its role in diagnosis.
No
The device description explicitly states it is a "sterile, disposable, multiple test head applicator," which is a physical hardware device used for administering substances.
Based on the provided information, the Allerhope® Allergy Skin Tester is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body.
- Allerhope Function: The Allerhope Allergy Skin Tester is used for the percutaneous administration of diagnostic allergenic extracts. This means it is used to apply substances to the skin, which is a procedure performed on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states "for the percutaneous administration of diagnostic allergenic extracts," which is a method of introducing substances into the skin.
Therefore, the Allerhope Allergy Skin Tester is a device used in a diagnostic procedure performed on the patient, not a test performed on a sample from the patient.
N/A
Intended Use / Indications for Use
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
Product codes (comma separated list FDA assigned to the subject device)
SCL, LDH
Device Description
Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Allerhope ® Allergy Skin Tester has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which are demonstrated in the table below:
| Characteristic | Standards Followed | Testing Conducted |
|---|---|---|
| Biocompatibility | ISO10993-5:2009 | In Vitro Cytotoxicity Test |
| ISO10993-10:2010 | Skin Sensitization Test Skin Irritation Test | |
| ISO10993-11:2006 | Acute Systemic Toxicity Test | |
| USP_NF32 | Endotoxin Test | |
| Sterility | ISO11737-2:2009 | Sterility Test |
| Performance | ISO178:2010 | Flexural Properties Test |
| ISO180:2000 | Lzod Impact Strength Test |
A comparison test over allergenic extracts delivery function has been conducted between subject device and predicate device. The result shows that the subject device can carry extracts as predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The HHS logo is a symbol of an eagle.
Procare Industrial Co., Limited c/o Jonathan Hu Technical Manager Gebiao Standard (Shanghai) Yangpu District Liaoyuan East Road Shangyang First Suite No.33 Room 303 Shanghai, 200093 CN CHINA
November 1, 2024
Re: K162917
Trade/Device Name: Allerhope® Allergy Skin Tester Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear Jonathan Hu:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 17, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480. David.Wolloscheck@fda.hhs.gov.
Sincerely,
David Wolloscheck -S
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Procare Industrial Co., Limited % Jonathan Hu Technical Manager Gebiao Standard (Shanghai) Yangpu District Liaoyuan East Road Shangyang First Suite No.33 Room 303 Shanghai, 200093 CN
Re: K162917
Trade/Device Name: Allerhope® Allergy Skin Tester Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LDH Dated: July 15, 2017 Received: July 18, 2017
Dear Jonathan Hu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
2
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162917
Device Name Allerhope® Allergy Skin Tester
Indications for Use (Describe)
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image contains the logo for Procare Industrial Co., Limited. The logo features a stylized blue cross with several blue dots clustered near the top right quadrant. To the right of the cross is the company name, "Procare Industrial Co., Limted," written in a simple, sans-serif font, also in blue. The overall design is clean and corporate, suggesting a company in the healthcare or industrial sector.
Date Prepared: Aug 8th, 2017
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | Procare Industrial Co., Limited | |
|---|---|---|
| Address: | No. 5-2-9-160, Science Avenue 89, Hi-Tech Zone | |
| Zhengzhou, Henan, China | ||
| Contact Name: | Wang Yanhong | |
| Telephone No.: | +86-13673363790 | |
| Fax No.: | +86-371-56663999 | |
| Email Address: | allergypricktest@aliyun.com |
2. Correspondent's Information
| Company Name: | Gebiao Standard (Shanghai) |
|---|---|
| Correspondent Name: | Jonathan HU |
| Telephone No.: | +86-15618986636 |
| Email Address: | hfk1102@163.com |
3. Trade Name, Common Name, Classification
| Trade Name: | Allerhope ® Allergy Skin Tester |
|---|---|
| Common Name: | Allergy Skin Tester |
| Mode Name: | PROSPT, PROSPT II |
| Regulation Classification | N/A |
| Product Code: | LDH |
| Classification Panel: | General Hospital |
| Device Class: | Unclassified |
4. Identification of Predicate Device(s)
The identified predicate within this submission is as follows:
The Multi-Test II of Lincoln Diagnostics, Incorporated have been cleared by FDA through 510(k) No. K961918 (Decision Date - Aug 7, 1996).
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Image /page/5/Picture/1 description: The image shows the logo for Procare Industrial Co., Limted. The logo consists of a blue medical cross with a cluster of blue dots near the top right quadrant. The text "Procare Industrial Co., Limted" is written in a blue sans-serif font to the right of the cross.
5. Description of the Device
Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.
6. Indication for Use
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
7. Technological Characteristics
The working situation and environment of Allerhope O Allergy Skin Tester is the same as that of the Multi-Test II of Lincoln Diagnostics, the technological characteristics of this product is designed to make same as that of the equivalence product. A comparison of technological characteristics is provided in the following table:
| Technological
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Product Code | LDH | LDH |
| Intended Use | The Allergy Skin Tester is for | |
| the percutaneous administration | ||
| of diagnostic allergenic extracts. | The sole indication for Multi- | |
| Test II is for the percutaneous | ||
| administration of diagnostic | ||
| allergenic extracts. | ||
| Product Structure | Multiple heads and points | Multiple heads and points |
| Material for Tester | ||
| Body | Acrylic plastic | |
| (PMMA) | Acrylic plastic | |
| (PMMA) | ||
| Color Additive | Titanium dioxide | Titanium dioxide |
| Sterilization Method | Gamma sterilization | EO sterilization |
| Packaging Method | Sterilization Pouch | Sterilization Pouch |
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510(k) Submission
Image /page/6/Picture/1 description: The image contains a logo for Procare Industrial Co., Limited. The logo features a blue cross-like symbol with rounded edges, accompanied by a cluster of small blue circles near the top-left corner. To the right of the symbol, the text "Procare Industrial Co., Limted" is written in a simple, sans-serif font, with the company name spread across two lines.
8. Discussion of Non-clinical Testing
The Allerhope ® Allergy Skin Tester has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which are demonstrated in the table below:
| Characteristic | Standards Followed | Testing Conducted |
|---|---|---|
| Biocompatibility | ISO10993-5:2009 | In Vitro Cytotoxicity Test |
| ISO10993-10:2010 | Skin Sensitization Test | |
| Skin Irritation Test | ||
| ISO10993-11:2006 | Acute Systemic Toxicity Test | |
| USP_NF32 | Endotoxin Test | |
| Sterility | ISO11737-2:2009 | Sterility Test |
| Performance | ISO178:2010 | Flexural Properties Test |
| ISO180:2000 | Lzod Impact Strength Test |
9. Substantial Equivalence
The intended uses, the operation methods, and the product theories of the subject device and the predicate's are same.
The sterilization method is replaced by gamma radiation, and the SAL=10-6 can be assured.
Two models in submission: PROSPT and PROSPT II have applied the structure of heads with points which is same as the predicate.
A comparison test over allergenic extracts delivery function has been conducted between subject device and predicate device. The result shows that the subject device can carry extracts as predicate device.
It is the conclusion that such difference between the subject and the predicate do not affect any of the intended use as the predicate device. And it is substantially equivalent to predicate devices in design, function, materials, operational principles and intended use.
10. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Procare Industrial Co., Limited concludes that Allerhope®Allergy Skin Tester is substantially equivalent to predicate device.