(213 days)
Not Found
No
The summary describes a photometric reader and chemical reagents for measuring lithium levels, with no mention of AI or ML.
No.
The device is described as an in vitro diagnostic device intended to measure lithium blood levels, which aids in the management of individuals taking lithium, but it does not directly treat or provide therapy itself.
Yes
The "Intended Use / Indications for Use" section states: "The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder)." This clearly indicates its use in aiding medical management, which is a diagnostic purpose. Additionally, the "Device Description" explicitly calls it an "in vitro diagnostic device."
No
The device description explicitly states that the system consists of three key components: Blood Cell Separator, Lithium Reagent, and InstaRead™ Lithium System photometric reader. These are physical hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended to measure lithium blood levels." Measuring substances in blood is a classic example of an in vitro diagnostic test.
- Device Description: The "Device Description" section clearly labels the InstaRead™ Lithium System as an "in vitro diagnostic device."
- Specimen Type: The system is designed to be used with "whole blood, serum, or EDTA-plasma," which are biological specimens typically analyzed in vitro.
- Purpose: The measurements are used "to aid in the management of individuals taking lithium for the treatment of mental disturbances," indicating a diagnostic or monitoring purpose related to a medical condition.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.
Product codes
JIH
Device Description
The InstaRead™ Lithium System is an in vitro diagnostic device designed to provide accurate and precise measures of patient lithium blood levels using serum or whole blood specimens in an easy to use system that can be utilized at the point of care by non-clinical laboratory personnel. The system consists of three key components starting with the Blood Cell Separator which is intended for use as a sample preparation aid to in vitro diagnostic testing systems where precise, micro-volume samples of a cell depleted fraction is required to be collected from a whole blood specimen. This is achieved through the attraction and capture of blood cells from a whole blood specimen by the lectin coating on the membrane. The residual liquid fraction, cell depleted continues to flow laterally to the tip of the membrane at which time the capillary pipette that has been inserted into the designated hole in the separator fills to the pipette's fixed volume and is ready to use. The precise volume (0.2 i l) that is captured using the separator is introduced to the second key component of the system, the Lithium Reagent. The lithium reagent is a colorimetric reagent whose active ingredient is a porphyrin compound that is highly specific and sensitive to lithium. Absorbance of light at 505 nm is increased by lithium concentration and is linear from 0.1 to 3.0 mEq/L of lithium, although the reportable range has been limited to 2.5 mEq/L. The third key component of the system is the InstaRead™ Lithium System photometric reader which is designed to measure the absorbance at 505 mm of a solution contained in a cuvette and report concentrations from 0.0 to 2.5 mEq/L of lithium on the reader's display system.
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
Physician's office use / Point of Care
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)
Studies were performed to evaluate the sensitivity, linearity, and precision of the InstaRead™ Lithium System. These studies demonstrated that the assay was sensitive to 0.1 mEq/L, the assay was linear between 0.1 and 2.5 mEq/L, and that precision estimates ranged from 0.00 to 0.08 standard deviations (SDs) when samples, targeted at various levels throughout the range, were assayed in multiple runs over multiple days. The percent coefficient of variation (%CV) of a control at ~1.5 mEq/L lithium was 6.4% when tested in 50 runs over five days (10 runs per day).
The InstaRead™ Lithium System was compared to a conventional laboratory system at two different clinical sites with a total of 200 serum samples (100 samples per site). The data showed the following linear regression and summary statistics:
SITE 1: n = 100, SLOPE = 0.970 (95% CI: 0.918 to 1.022), Y-INTERCEPT = 0.03 (95% CI: -0.04 to 0.10), Syx = 0.14, "r" = 0.966
SITE 2: n = 100, SLOPE = 1.025 (95% CI: 0.966 to 1.085), Y-INTERCEPT = -0.07 (95% CI: -0.15 to 0.02), Syx = 0.17, "r" = 0.961
Total: n = 200, SLOPE = 0.998 (95% CI: 0.958 to 1.038), Y-INTERCEPT = -0.02 (95% CI: -0.07 to 0.04), Syx = 0.16, "r" = 0.962
In a second study, 29 spiked whole blood samples were assayed by the InstaRead™ Lithium System at a doctor's office, and the corresponding plasma samples were assayed by a routine chemistry analyzer. The data showed: n = 29, SLOPE = 0.833 (95% CI: 0.772 to 0.895), Y-INTERCEPT = 0.05 (95% CI: -0.03 to 0.13), Sy/x = 0.10, "r" = 0.983.
Two separate studies were conducted to evaluate InstaRead performance with fingerstick whole blood samples.
Fingerstick Study #1: 40 native fingerstick samples. n = 40, SLOPE = 0.847 (95% CI: 0.735 to 0.958), Y-INTERCEPT = 0.02 (95% CI: -0.07 to 0.11), Sy/x = 0.14, "r" = 0.928.
Fingerstick Study #2: 20 samples. n = 20, SLOPE = 1.194 (95% CI: 1.129 to 1.258), Y-INTERCEPT = 0 (95% CI: -0.06 to 0.06), Sy/x = 0.06, "r" = 0.994.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.1 mEq/L
Correlation Coefficient to Predicate System: 0.962
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.
0
DEC 1 9 2003
Image /page/0/Picture/1 description: The image shows the logo for Akers Biosciences Inc. The logo consists of a large, bold "A" inside of a circle, followed by the text "AKERS" in large, bold letters. Below "AKERS" is the text "BIOSCIENCES INC." in smaller, but still bold, letters.
201 Grove Road Thorofare, New Jersey 08086 (856) 848-8698 • Fax (856) 848-0269
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K031579.
807.92 (a)(1): Name: . . . . Akers Laboratories, Inc. 201 Grove Road Address: Thorofare, NJ 08086 (856) 848-8698 Phone: (856) 848-0269 FAX: Barbara A. Bagby Contact:
807.92 (a)(2): Device Name - trade name and common name, and classification
| Trade name: | InstaRead™ Lithium System |
|---|---|
| Common name: | Lithium test system |
| Classification: | 21 CFR 862,3560 |
| Product Code: JIH |
807.92 (a)(3): Identification of the legally marketed predicate device InstaRead™ Lithium System is substantially equivalent to the Vitros Lithium System, Johnson & Johnson Clinical Diagnostics, Inc .- Rochester, NY K934106.
807.92 (a)(4): Device Description
The InstaRead™ Lithium System is an in vitro diagnostic device designed to provide accurate and precise measures of patient lithium blood levels using serum or whole blood specimens in an easy to use system that can be utilized at the point of care by non-clinical laboratory personnel
The system consists of three key components starting with the Blood Cell Separator which is intended for use as a sample preparation aid to in vitro diagnostic testing systems where precise, micro-volume samples of a cell depleted fraction is required to be collected from a whole blood specimen. This is achieved through the attraction and capture of blood cells from a whole blood
1
specimen by the lectin coating on the membrane. The residual liquid fraction, cell depleted continues to flow laterally to the tip of the membrane at which time the capillary pipette that has been inserted into the designated hole in the separator fills to the pipette's fixed volume and is ready to use.
The precise volume (0.2 i l) that is captured using the separator is introduced to the second key component of the system, the Lithium Reagent. The lithium reagent is a colorimetric reagent whose active ingredient is a porphyrin compound that is highly specific and sensitive to lithium. Absorbance of light at 505 nm is increased by lithium concentration and is linear from 0.1 to 3.0 mEq/L of lithium, although the reportable range has been limited to 2.5 mEq/L.
The third key component of the system is the InstaRead™ Lithium System photometric reader which is designed to measure the absorbance at 505 mm of a solution contained in a cuvette and report concentrations from 0.0 to 2.5 mEq/L of lithium on the reader's display system.
807.92 (a)(5): Intended use
The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.
2
| CHARACTERISTIC | InstaRead™
Lithium System | Vitros Lithium System
K934106 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measures lithium levels in
Serum, plasma and whole blood | Measures lithium levels in
serum and plasma |
| Indications for Use | Used in the management and monitoring of
lithium levels in psychiatric patients treated with lithium for manic depression illness | Used in the management and monitoring of
lithium levels in psychiatric patients treated with lithium for manic depression illness |
| Detection Methodology | Colorimetric Spectrophotometry | Colorimetric Spectrophotometry |
| Test Sample | Serum; finger stick and venous EDTA whole blood and EDTA plasma | Serum; sodium heparin and EDTA plasma |
| Reading System | Handheld;
battery powered reader | Benchtop;
AC Analyzer |
| Testing Environment | Point of Care | Laboratory Use |
| Reactive Ingredient | Lithium Sensitive Dye | Lithium Sensitive Dye |
| Preparation Materials | Provided | Not Provided |
| Calibration Requirements | Start of each refill pack (24 tests);
system service or maintenance,
out of range quality control results;
or once every month | Lot number changes;
system service or maintenance,
out of range quality control results;
or once every six months |
| Performance Range | 0.1 mEq/L to 2.5 mEq/L | 0.2 mEq/L to 4.0 mEq/L |
| Sensitivity | 0.1 mEq/L | 0.2 mEq/L |
| Correlation Coefficient to
Predicate System | 0.962 | 0.991 |
| Analyte Limitations: | | |
| Sodium | 200 mmol/L | 160 mmol/L |
| Potassium | 8.0 mmol/L | 10.0 mmol/L |
| Calcium | 4.0 mmol/L | 5.0 mmol/L |
| Magnesium | 2.0 mmol/L | 5.0 mmol/L |
| Iron | 200 umol/L | 124 umol/L |
| Zinc | 250 umol/L | 770 umol/L |
| Copper | 250 umol/L | 470 umol/L |
| Hemoglobin | 1000 mg/dL | 100 mg/dL |
| Free Bilirubin | 45 mg/dL | 20 mg/dL |
807.92 (a)(6): Technological Similarities and Differences to Predicate
18 - 12
The following chart exhibits similarities and differences between the InstaRead™ Lithium System and the Vitros Lithium System.
The differences in the two testing platforms do not raise new issues of safety and effectiveness.
Carolina Carolina
3
807.92 (b)(1): Brief Description of Non-clinical Data
Studies were performed to evaluate the sensitivity, linearity, and precision of the InstaRead™ Lithium System. These studies demonstrated that the assay was sensitive to 0.1 mEq/L, the assay was linear between 0.1 and 2.5 mEq/L, and that precision estimates ranged from 0.00 to 0.08 standard devations (SDs) when samples, targeted at various levels throughout the range, were assayed in multiple runs over multiple days. The percent coefficient of variation (%CV) of a control at ~1.5 mEq/L lithium was 6.4% when tested in 50 runs over five days (10 runs per dav).
807.92 (b)(2): Brief Description of Clinical Data
The InstaRead™ Lithium System was compared to a conventional laboratory system at two different clinical sites with a total of 200 serum samples (100 samples per site). The data showed the following linear regression and summary statistics:
| SITE | n | SLOPE | Y-INTERCEPT | Syx | "r" | ||
|---|---|---|---|---|---|---|---|
| slope | 95% CI* | y-intercept | 95% CI* | ||||
| 1 | 100 | 0.970 | 0.918 to 1.022 | 0.03 | -0.04 to 0.10 | 0.14 | 0.966 |
| 2 | 100 | 1.025 | 0.966 to 1.085 | -0.07 | -0.15 to 0.02 | 0.17 | 0.961 |
| Total | 200 | 0.998 | 0.958 to 1.038 | -0.02 | -0.07 to 0.04 | 0.16 | 0.962 |
| SERUM STUDY LINEAR REGRESSION |
|---|
*CI = Confidence Intervals
In a second study, 29 spiked whole blood samples were assayed by the InstaRead™ Lithium System at a doctor's office, and the corresponding plasma samples were assayed by a routine chemistry analyzer. The data appear below.
| SLOPE | Y-INTERCEPT | |||||
|---|---|---|---|---|---|---|
| n | slope | 95% CI | y-int | 95% CI | Sy/x | "r" |
| 29 | 0.833 | 0.772 to 0.895 | 0.05 | -0.03 to 0.13 | 0.10 | 0.983 |
WHOLE BLOOD STUDY LINEAR REGRESSION
Two separate studies were conducted to evaluate InstaRead performance with fingerstick whole blood samples. One study included 40 native fingerstick samples, and the second study included 20 samples. In each study, two fingerstick samples were assayed by the InstaRead™ Lithium System at a doctor's office, and venous blood was collected into a neutral tube and processed to serum. The serum was assayed by atomic absorption at a reference laboratory. The two data appear below
4
| n | SLOPE
slope | 95% CI | Y-INTERCEPT
y-int | 95% CI | Sy/x | "r" |
|----|----------------|----------------|----------------------|---------------|------|-------|
| 40 | 0.847 | 0.735 to 0.958 | 0.02 | -0.07 to 0.11 | 0.14 | 0.928 |
FINGERSTICK STUDY #1 LINEAR REGRESSION
FINGERSTICK STUDY #2 LINEAR REGRESSION
| n | SLOPE | Y-INTERCEPT | Sy/x | "r" | ||
|---|---|---|---|---|---|---|
| 20 | slope | |||||
| 1.194 | 95% CI | |||||
| 1.129 to 1.258 | y-int | |||||
| 0 | 95% CI | |||||
| -0.06 to 0.06 | 0.06 | 0.994 |
807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing
States of the states and the states of the states of
InstaRead™ Lithium System was evaluated for non-clinical and clinical performance characteristics in comprehensive studies. These studies demonstrated that the test is safe and effective for intended use.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular seal that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEC 1 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Erika B. Ammirati Regulatory Consultant Akers Biosciences Inc. 201 Grove Road Thorofare, NJ 08086
Re: K031579 Trade/Device Name: InstaRead™ Lithium System Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: JIH Dated: September 24, 2003 Received: September 24 24, 2003
Dear Ms. Ammirati:
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.
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).
6
Page 2 -
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.
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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
STATEMENT OF INTENDED USE
510(K) Number (if known): K031579
Device Name: InstaRead™ Lithium System
Indications for Use:
The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over -the-Counter Use ______ |
| (Per 21 CFR 801.109) | ||
| Division Sign-Off | for Jean Cooper | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | ||
| 510(k) | K031579 |