(105 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the AnemiaPro™ Self-Screener, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it does describe the performance studies conducted and what they aimed to evaluate. The results indicate that the device met the implicit criteria for substantial equivalence to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Precision (Consistency of results) | Studied as a performance characteristic. Specific quantitative results are not provided in this summary, but the context implies acceptable precision for substantial equivalence. |
| Linearity (Accuracy across a range of values) | Studied as a performance characteristic. Specific quantitative results are not provided in this summary, but the context implies acceptable linearity for substantial equivalence. |
| Analytical Accuracy (Closeness to true value) | Studied as a performance characteristic. Specific quantitative results for accuracy are not provided, but the statement "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" directly addresses this. |
| Correlation (Agreement with predicate devices) | "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 [Cell Dyn 3700 Analyzer and HemoCue B-Hemoglobin Instrument]." This is a key finding demonstrating substantial equivalence. |
| Interference Effects (Resistance to interfering substances) | The AnemiaPro™ Self-Screener was evaluated for effects of interferences. The summary implies that any interference effects were within acceptable limits, though specific data is not provided. |
| Sample Environmental Factors (Stability under various conditions) | The AnemiaPro™ Self-Screener was evaluated for effects of sample environmental factors. The summary implies that the device performs acceptably under varying environmental factors, though specific data is not provided. |
| Substantial Equivalence to legally marketed predicate devices | Explicitly stated: "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." |
Study Information
The document provides a summary of the performance studies.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a single number. The studies were conducted on "self-collected capillary blood samples from volunteer study subjects." The phrase "three different geographical trial sites" suggests a decent number of participants, but the exact number isn't provided in this summary.
- Data Provenance: Prospective. The studies involved "volunteer study subjects" from whom samples were "collected." Samples were collected from "three different geographical trial sites."
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- "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."
- The "health care professional" served as the primary expert for professional capillary blood sample collection.
- "Venous samples were express shipped to BIOSAFE Laboratories for hemoglobin analysis using the predicate methods." This implies that the predicate devices' results, performed by qualified laboratory personnel at BIOSAFE Laboratories, served as the ground truth. The specific number and qualifications of these laboratory personnel are not provided.
-
Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for conflicting results. The comparison was made between the AnemiaPro™ device, professionally collected capillary samples, and venous blood samples tested on predicate devices. It seems the predicate device results served as the reference standard.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers assisting with the device's output and measuring their improvement was not conducted or described. This device is an in vitro diagnostic (IVD) for determining hemoglobin concentration, not an imaging or diagnostic aid for human interpretation.
-
Standalone (Algorithm Only) Performance:
- Yes, the performance study effectively evaluates the standalone performance of the AnemiaPro™ Self-Screener. The device provides "determination of hemoglobin concentration," which is a direct output. Its performance was compared against predicate devices, indicating its standalone accuracy.
-
Type of Ground Truth Used:
- The primary ground truth appears to be comparison with predicate devices (Cell Dyn 3700 Analyzer and HemoCue B-Hemoglobin Instrument) using venous blood samples, which are generally considered a gold standard for hemoglobin measurement in a clinical setting. Professionally collected capillary blood samples also served as a comparative reference.
-
Sample Size for the Training Set:
- The document does not mention a separate training set or its sample size. The description focuses on "performance studies" and "clinical trials" which are typically used for validation. For a device like this, the 'training' often refers to assay development and optimization, rather than a machine learning training set as in AI.
-
How the Ground Truth for the Training Set Was Established:
- Since a separate "training set" in the context of machine learning or complex algorithms is not described, the method for establishing ground truth for such a set is not applicable or provided in this summary. The fundamental accuracy and comparison were based on the predicate devices during the performance studies.
{0}------------------------------------------------
2279
G - 1
| DEC 15 2004 | |||
|---|---|---|---|
| 1) | Submitter's NameAddress, contact | 510(k) SummaryBIOSAFE Laboratories, Inc.100 Field Drive, Suite 240Lake Forest, IL 60045 | |
| Phone: (847) 234-8111FAX: (847) 234-8222 | |||
| Contact Person: | Jack A. Maggiore, PhDBIOSAFE 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 concentrationin 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-collectand 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 throughthe test strip, and the migration front is made visible by staining withan impregnated dye. The plasma migration distance is linearly andinversely proportional to hemoglobin concentration. The kit iscomprised of a blood testing unit packaged in a foil pouch, alcoholprep pad, disposable lancets, gauze pad, bandage strip, and collectioninstructions containing information about anemia.. | |
| 5) | Intended Use | The AnemiaPro ™ Self-Screener is intended for over-the-counterdistribution, for the determination of hemoglobin concentration in aself-collected capillary whole blood sample. The device is notintended 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.
{3}------------------------------------------------
Page 2
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
§ 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.