(64 days)
The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity Range | N/A (demonstrated over usable range) | 0.1 to 15 mg/dL |
| Linearity Regression (Slope) | Close to 1.00 | 0.991 |
| Linearity Regression (Intercept) | Close to 0 | -0.05 mg/dL |
| Linearity Regression (Correlation Coefficient, r) | Close to 1.000 | 1.000 |
| Linearity Regression (Standard Error of Y, SYX) | N/A | 0.11 mg/dL |
| Precision (Within-Run %CV) | N/A (compared to predicate or industry standard, generally low) | Serum 1: 3.2% |
| Precision (Total %CV) | N/A (compared to predicate or industry standard, generally low) | Serum 1: 5.0% |
| Method Comparison (Deming Regression Slope) | Close to 1.00 | 1.001 |
| Method Comparison (Deming Regression Intercept) | Close to 0 | -0.17 mg/dL |
| Method Comparison (Standard Error of Regression, Syx) | N/A | 0.17 mg/dL |
| Detection Limit | N/A (should be clinically acceptable for phosphorus) | 0.1 mg/dL |
| Onboard Reagent Stability | Total imprecision < 0.2 mg/dL or 4% | Claimed and documented: < 0.2 mg/dL or 4% over 14 days |
| Calibration Stability | Total imprecision < 0.2 mg/dL or 4% | Claimed and documented: < 0.2 mg/dL or 4% over 7 days |
Note on "Acceptance Criteria (Implied)": The document performs a substantial equivalence claim against an existing device (Beckman Synchron Phosphorus Reagent). Therefore, the "acceptance criteria" are not explicitly stated as hard numerical thresholds within this document, but rather are demonstrated by showing performance comparable to, or within acceptable limits for, clinical laboratory assays of this type, often implicitly benchmarked against the predicate device or established industry guidelines (like NCCLS EP3-T for precision). For regression analyses, slopes near 1, intercepts near 0, and high correlation coefficients (r-values) are generally considered good.
2. Sample sized used for the test set and the data provenance
- Linearity: 27 samples (implied from "n=27" associated with linearity regression, though the context indicates "% of the rod" which is a typo and likely meant "range" or "rod" as a unit for linearity standards). The samples used were "linearity standards that span the usable range."
- Precision:
- Serum 1: n = 60 replicates
- Serum 2: n = 60 replicates
- Serum 3: n = 60 replicates
The samples were "commercially available control serum."
- Method Comparison: n = 115 patient specimens. The specimens were "Mixed serum and plasma specimens, collected from adult patients." The data provenance is not explicitly stated as country of origin, but it is retrospective as the specimens were already collected.
- Detection Limit: 30 replicates of a diluted serum pool.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an in vitro diagnostic (IVD) like a phosphorus reagent, "ground truth" is typically established by:
- Reference methods for linearity standards.
- Certified values for control sera used in precision studies.
- The results from a well-established, legally marketed comparative method (predicate device) in method comparison studies.
No human experts are explicitly mentioned as establishing ground truth in this context; rather, the "truth" is derived from established analytical methods and reference materials.
4. Adjudication method for the test set
Not applicable. The "adjudication method" (e.g., 2+1, 3+1) typically refers to a process where multiple human readers independently interpret data, and discrepancies are resolved by a consensus or a senior expert. This concept is relevant for imaging or diagnostic algorithms where human interpretation is the primary ground truth. For an IVD reagent, the performance is assessed against quantitative analytical metrics, not human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document describes a new reagent for quantitative chemical analysis, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire study described is a standalone performance study of the ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System. It assesses the analytical performance of the reagent (linearity, precision, method comparison, detection limit, stability) without human intervention in the result generation itself, beyond standard laboratory practices for sample handling and system operation. There is no human-in-the-loop component described for the device's performance.
7. The type of ground truth used
- Linearity: Based on "standard values" from "linearity standards that span the usable range." These standards would have known, certified phosphorus concentrations.
- Precision: Based on "commercially available control serum" which have established target values and acceptable ranges.
- Method Comparison: The "competitive reagent" (predicate device) serves as the "ground truth" or reference for comparison. The assumption is that the predicate device is accurate and provides clinically acceptable results.
- Detection Limit: Derived from the statistical analysis of repetitive assays of a "diluted serum pool."
- Stability: Assessed against the initial, presumably accurate, values of "serum controls" over time.
In summary, the ground truth is primarily based on reference materials, certified controls, and comparison to an established predicate device.
8. The sample size for the training set
Not applicable. This device is an in vitro diagnostic reagent, not an AI or machine learning algorithm that requires a "training set." Its performance is based on chemical reactions and photometric measurements, validated through analytical studies.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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MAR 0 7 2003
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1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
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 ATAC PAK Phosphorus Reagent Kit is intended for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
The ATAC PAK Phosphorus Reagent Kit is substantially equivalent to the Beckman Synchron Phosphorus Reagent, product 465145, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of inorganic phosphorus using the ATAC PAK Phosphorus Reagent is linear from 0.1 to 15 mg/dL. as shown by the recovery of linearity standards that span the usable range. Regression statistics compare stoneries to standard values. These statistics are shown below.
$$\text{(ATAC Recoveries)} = -0.05 \text{ mg/dL} + 0.991 \times \text{(Standard Value)}, \quad \text{r} = 1.000, \quad \text{s}_{\text{Y}\text{X}} = 0.11 \text{ mg/dL}, \quad \text{n} = 27% \text{ of the rod}$$
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 1.8 | 0.06 | 3.2% | 0.09 | 5.0% |
| Serum 2 | 60 | 4.3 | 0.10 | 2.3% | 0.15 | 3.5% |
| Serum 3 | 60 | 6.7 | 0.15 | 2.3% | 0.23 | 3.5% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for inorganic phosphorus using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
ATAC 8000 = -0.17 mg/dL + 1.001 x Competitive Reagent sv.x= 0.17 mg/dL n = 115 range = 0.9 - 9.6 mg/dL
The detection limit of 0.1 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.049 mg/dL. Consequently, the detection limit is reported as 0.1 mg/dL, which is the round-off error of the assay.
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of phosphorus over the test periods are less than 0.2 mg/dL or 4%.
Wynn Stocking
Wynn Stocking Manager of Regulatory Affairs Elan, Brea California
510(k) Notification, ATAC PAK Phosphorus Reagent Kit, 31 December, 2002, p 63
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 7 2003
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821
K030015 Trade/Device Name: ATAC PAK Phosphorus Reagent Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) test system Regulatory Class: Class I Product Code: CEO Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Stocking:
Re:
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. Iisting 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).
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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 Putman
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
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KosoonS
510(k) Number (if known):
Device Name:
ATAC PAK Phosphorus Reagent
Indications for Use:
The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Coope
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K630015
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.