(105 days)
Cell Dyn 3700 Analyzer, HemoCue B-Hemoglobin Instrument
Not Found
No
The device description and performance studies focus on a nitrocellulose-based test strip and chemical reaction for measurement, with no mention of AI/ML algorithms or data processing beyond basic correlation.
No.
The device is intended for the determination of hemoglobin concentration, which is a diagnostic purpose, not a therapeutic one. It screens for a condition (anemia) but does not treat it.
Yes
The device is described as determining "hemoglobin concentration," which is a measurement used to aid in the diagnosis of anemia. Its intended use as a "Self-Screener" for this purpose fits the definition of a diagnostic device.
No
The device description clearly states it is a kit containing physical materials, including a test unit with a nitrocellulose-based test strip, lancets, gauze, and bandages, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "determination of hemoglobin concentration in a self-collected capillary whole blood sample." This is a diagnostic measurement performed on a biological sample taken from the body.
- Device Description: The device is a kit containing materials to "self-collect and test a capillary blood sample." The test unit uses a "nitrocellulose-based test strip" and measures "plasma migration distance" to determine hemoglobin concentration. This describes a laboratory-type test performed outside of the body.
- Anatomical Site: The sample is a "capillary whole blood sample," which is a biological specimen.
These characteristics clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the body to help diagnose disease or other conditions.
N/A
Intended Use / Indications for Use
The AnemiaPro ™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.
Product codes
KHG, GIG
Device Description
The device is a kit containing the materials necessary to self-collect
and test a capillary blood sample using a single-use, disposable unit.
The test unit is a self-contained plastic housing for a nitrocellulose-
based test strip, which employs the principals of blood cell separation.
The plasma that is obtained during blood separation migrates through
the test strip, and the migration front is made visible by staining with
an impregnated dye. The plasma migration distance is linearly and
inversely proportional to hemoglobin concentration. The kit is
comprised of a blood testing unit packaged in a foil pouch, alcohol
prep pad, disposable lancets, gauze pad, bandage strip, and collection
instructions containing information about anemia.
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
The device is not intended for use in neonates.
Intended User / Care Setting
over-the-counter distribution
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
Performance studies were conducted on self-collected capillary blood samples from volunteer study subjects at three different geographical trial sites. A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare venous hemoglobin results to those obtained from both capillary blood samples tested on the Anemia Test Devices. Venous samples were express shipped to BIOSAFE Laboratories for hemoglobin analysis using the predicate methods.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics studied included precision, linearity, analytical accuracy and correlation. In addition, the AnemiaPro™ Self-Screener was evaluated for effects of interferences and sample environmental factors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cell Dyn 3700 Analyzer, HemoCue B-Hemoglobin Instrument
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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2279
G - 1
| DEC 15 2004 | |||
|---|---|---|---|
| 1) | Submitter's Name | ||
| Address, contact | 510(k) Summary | ||
| BIOSAFE Laboratories, Inc. | |||
| 100 Field Drive, Suite 240 | |||
| Lake Forest, IL 60045 | |||
| Phone: (847) 234-8111 | |||
| FAX: (847) 234-8222 | |||
| Contact Person: | Jack A. Maggiore, PhD | ||
| BIOSAFE Laboratories, Inc. | |||
| (773) 693-0400, x253 | |||
| Date Prepared: | August 19, 2004 | ||
| 2) | Device Name | Proprietary Name: | AnemiaPro ™ Self-Screener |
| Common Name: | Device to determine hemoglobin concentration | ||
| in capillary whole blood | |||
| Classification Names: Whole Blood Hemoglobin Assays | |||
| (21 CFR 864.7500) | |||
| 3) | Predicate Devices | Cell Dyn 3700 Analyzer, Abbott Laboratories, Inc. | |
| HemoCue B-Hemoglobin Instrument, HemoCue, Inc. | |||
| 4) | Device Description | The device is a kit containing the materials necessary to self-collect | |
| and test a capillary blood sample using a single-use, disposable unit. | |||
| The test unit is a self-contained plastic housing for a nitrocellulose- | |||
| based test strip, which employs the principals of blood cell separation. | |||
| The plasma that is obtained during blood separation migrates through | |||
| the test strip, and the migration front is made visible by staining with | |||
| an impregnated dye. The plasma migration distance is linearly and | |||
| inversely proportional to hemoglobin concentration. The kit is | |||
| comprised of a blood testing unit packaged in a foil pouch, alcohol | |||
| prep pad, disposable lancets, gauze pad, bandage strip, and collection | |||
| instructions containing information about anemia.. | |||
| 5) | Intended Use | The AnemiaPro ™ Self-Screener is intended for over-the-counter | |
| distribution, for the determination of hemoglobin concentration in a | |||
| self-collected capillary whole blood sample. The device is not | |||
| intended for use in neonates. | |||
| 6) Comparison to predicate device | The AnemiaPro™ Self-Screener has technological characteristics that are substantially equivalent to that of the predicate devices listed above. The AnemiaPro™ Self-Screener provides components that permit self-collection and testing of a capillary blood sample for determination of hemoglobin Results of clinical trials have shown that self-collected capillary samples correlate closely with paired venous whole blood samples tested with the aforementioned predicate devices. |
Continued on next page
1
510(k) Summary, continued
- Performance Studies Performance studies were conducted on self-collected capillary blood samples from volunteer study subjects at three different geographical trial sites. A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare venous hemoglobin results to those obtained from both capillary blood samples tested on the Anemia Test Devices. Venous samples were express shipped to BIOSAFE Laboratories for hemoglobin analysis using the predicate methods.
Performance characteristics studied included precision, linearity, 8) Test Summary analytical accuracy and correlation. In addition, the AnemiaPro™ Self-Screener was evaluated for effects of interferences and sample environmental factors.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jack A. Maggiore, Ph.D. President, Chief Scientific Officer BIOSAFE Laboratories, Inc. 8600 W. Catalpa Chicago. Illinois 60656
DEC 1 5 2004
K042379 Re:
Trade/Device Name: AnemiaPro™ Self-Screener Regulation Number: 21 CFR § 864.7500 Regulation Name: Whole Blood Hemoglobin Assays Regulatory Class: II Product Code: KHG, GIG Dated: November 8, 2004 Received: November 12, 2004
Dear Dr. Maggiore:
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 regurements 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
. .
4
Indications for Use
510(k) Number (if known): K042379
Device Name:
Indications For Use: The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of-CDRH, Office of Dexice Evaluation (ODE)
Josephine Bautista
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042379