(75 days)
The Nichols Advantage® 25-Hydroxyvitamin D assay is for use only on the Nichols Advantage® Specialty System. The Nichols Advantage 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency in an adult population. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Nichols Advantage 25-OH-D (NA 25-OH-D) contains sufficient reagents for 100 tests. The NA 25-OH-D is an automated 25-OH-D assay for use only on the Nichols Advantage Immunoassay System.
This looks like a 510(k) summary for a medical device called the "Nichols Advantage® 25-Hydroxyvitamin D" assay. It's an immunoassay designed to measure 25-hydroxyvitamin D (25-OH-D) levels in serum or plasma.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a separate, clear table with pass/fail thresholds. Instead, it presents performance characteristics for both the new device and the predicate device, implying that equivalence to the predicate device's performance is the acceptance criterion.
However, based on the Comparison of Performance Characteristics table and the Comparison to Predicate Device section, we can infer some criteria and compare them to the reported performance.
| Feature | Acceptance Criteria (Inferred from Predicate) | Nichols Advantage® 25-Hydroxyvitamin D Reported Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to the DiaSorin 25-Hydroxyvitamin D 125I RIA kit, specifically: - Passing & Bablok slope close to 1 - Passing & Bablok intercept close to 0 - Pearson correlation (r) value indicating strong correlation - High overall agreement using a 20 ng/mL cutoff. | Y=1.1(X) - 0.6 (95% cf slope: 0.94 to 1.27; 95% cf intercept: -4.6 to 2.1) Pearson correlation r=0.84 (95%cf: 0.76-0.89) Relative agreement at 20 ng/mL or less: 97.8% Relative agreement at 20 ng/mL and higher: 90.6% Overall agreement (20 ng/mL cutoff): 93.9% |
| Analytical Sensitivity | ≤ 1.5 ng/mL (Predicate) | 4 ng/mL |
| Functional Sensitivity | 2.5 ng/mL (Predicate) | 7 ng/mL |
| Within-Run Precision (%CV) | 8.6-12.5% (Predicate) | 3.0-4.5% (Overall study: Ave. CV 4.7%, Median CV 3.3%) |
| Total Precision (%CV) | 8.2-11.0% (Predicate) | 6.4-14.5% |
| Recovery | 92-119% (Predicate) | 90-99% |
| Linearity | 96-110% (Predicate) | 80-109% |
| Specificity (Cross-reactivity) | Detailed comparative percentages for various Vitamin D derivatives (e.g., Vitamin D2, D3, 25-OH-D2, 25-OH-D3, 24,25(OH)2D3, 25-26-OH2D3, 1,25(OH)2D3) with the predicate. | Closely comparable percentages for various Vitamin D derivatives, e.g., 25-OH-D2 and 25-OH-D3 both 100% for both devices; some differences in minor metabolites are noted and discussed as technology differences. |
| Reportable Range | 5.0-100 ng/mL (Predicate) | 7-120 ng/mL |
Analysis of Performance vs. Criteria:
- Method Comparison: The Passing & Bablok results (Y=1.1(X) - 0.6, slope 0.94 to 1.27, intercept -4.6 to 2.1) and Pearson correlation (r=0.84) demonstrate a good correlation and substantial equivalence, despite some noted bias for higher values. The high overall agreement (93.9%) at the 20 ng/mL cutoff further supports this.
- Precision: The Nichols Advantage device shows better within-run precision (3.0-4.5% vs. 8.6-12.5% for predicate) and comparable total precision.
- Sensitivity: The analytical and functional sensitivities for the Nichols Advantage (4 ng/mL and 7 ng/mL) are higher (less sensitive) than the predicate (≤ 1.5 ng/mL and 2.5 ng/mL). The reportable range for the new device also starts higher (7 ng/mL vs. 5.0 ng/mL). This is a point of difference but not explicitly stated as failing an acceptance criterion, especially if the device is intended for "assessment of vitamin D sufficiency" where clinical cutoffs are typically higher (e.g., 20 ng/mL). The device still covers the critical 20 ng/mL cutoff for sufficiency.
- Recovery and Linearity: Both are within generally acceptable ranges and comparable to the predicate.
- Specificity: While there are minor differences in cross-reactivity percentages for some metabolites (e.g., 25-26-OH2D3 and 1,25(OH)2D3), these are acknowledged as relating to "differences in immunoassay technology" and not affecting the intended use.
Study Proving Acceptance:
The primary study proving the device meets the acceptance criteria is a method comparison study against the legally marketed predicate device, the DiaSorin 25-Hydroxyvitamin D 125I RIA kit.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Method Comparison: 111 total samples were initially assayed (each in duplicate).
- 80 samples were identified as being within the reportable ranges of both methods and had acceptable precision. These 80 samples were used for the statistical analysis (Deming, Passing & Bablok, Pearson).
- 19 samples were below the reportable range of the subject device.
- 12 samples were deleted due to unacceptable imprecision (>4 standard deviations), primarily associated with the DiaSorin assay.
- Thus, the core statistical comparison was based on 80 samples. The concordance chart combined the 80 precise samples and the 19 below-range samples, making the concordance analysis based on 99 samples.
- Clinical Study (separate): 100 patients with a diagnosis of chronic renal insufficiency.
- Method Comparison: 111 total samples were initially assayed (each in duplicate).
- Data Provenance: The document does not specify the country of origin for the samples. It mentions "samples were assayed over 3 days in 3 different runs," indicating the data was generated specifically for this comparison study, making it prospective data collection for the method comparison. The clinical study on renal patients is also likely prospective or involved newly collected samples for evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the method comparison study, the "ground truth" is established by the predicate device (DiaSorin 25-Hydroxyvitamin D 125I RIA kit). There were no human experts establishing ground truth; it's a comparison of two analytical methods.
- For the clinical study, the "ground truth" for vitamin D deficiency/insufficiency was assessed using the device's results in conjunction with "biochemical measures of disordered calcium mineral ion metabolism." It does not explicitly state that experts established ground truth for each case. The study aimed to show the device's consistency with known clinical relationships (e.g., renal failure and low 25-OH-D).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. For the method comparison, the reference is the predicate device's measurement. Discordant results are analyzed statistically, not adjudicated by experts.
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 an in vitro diagnostic (IVD) assay, not an AI-powered diagnostic imaging or interpretation device that would involve human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes. The device is an automated immunoassay system. Its performance is measured as a standalone analytical instrument. There is no human-in-the-loop performance component in the direct interpretation of the assay result, although clinicians use the result in conjunction with other data for patient management.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Method Comparison: The ground truth is the results from the predicate device (DiaSorin 25-Hydroxyvitamin D 125I RIA kit). This is a comparison against a previously validated and legally marketed analytical method.
- Clinical Study: The ground truth for correlating 25-OH-D levels with clinical status was based on a diagnosis of chronic renal insufficiency and "biochemical measures of disordered calcium mineral ion metabolism." This leans towards clinical outcomes/correlation data rather than a single definitive ground truth like pathology for each case.
8. The sample size for the training set:
- The document does not explicitly describe a training set. This is common for traditional immunoassay development, where a "training set" in the machine learning sense isn't typically used. Instead, development involves optimizing reagents, calibration, and assay parameters, often through iterative testing with various samples, but not usually in a formally defined "training set" that precedes a distinct "test set" in the way an AI algorithm might require. The samples mentioned (111 for method comparison, 100 for clinical study) are for validation, not distinct training.
9. How the ground truth for the training set was established:
- As a formal "training set" is not explicitly defined or discussed in the context of this traditional immunoassay, the concept of establishing ground truth for it is not applicable here. The overall "truth" for this device's validation is based on its analytical accuracy and its agreement with a predicate device, which itself was previously validated.
{0}------------------------------------------------
510(k) Summary 12.0
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Name of Manufacturer, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675 Phone: 949-240-5260 FAX: 949-240-5313 Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: September 20, 2001
2. Device Name:
| Trade/Proprietary Name: | Nichols Advantage® 25-Hydroxyvitamin D |
|---|---|
| Common Name: | 25-OH-D Immunoassay |
| Classification Name: | Vitamin D test system |
-
Classification: Class II ട്.
Regulation Number: 862.1825 Product Code: MRG. Clinical Chemistry -
DiaSorin 25-Hydroxyvitamin D 1251 RIA kit 4. Predicate Device:
Device Description: 5.
The Nichols Advantage 25-OH-D (NA 25-OH-D) contains sufficient reagents for 100 tests. The NA 25-OH-D is an automated 25-OH-D assay for use only on the Nichols Advantage Immunoassay System.
Intended Use: 6.
The Nichols Advantage® 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydrxoyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
7. Comparison to Predicate Device:
The Nichols Advantage 25-OH-D (Y) is substantially equivalent to the DiaSorin 25-Hydroxvyitamin D 125] RIA kit (X). N=99 samples were used in a split sample method comparison study following the NCCLS EP9-A quidelines. For n=80 samples within the reportable ranges of each method, the Passing & Bablok method comparison demonstrates: Y=1.1(X) - 0.6 (95% cf slope: 0.94 to 1.27; 95% cf intercept: -4.6 to 2.1), and a Pearson correlation r=0.84 (95%cf: 0.76-0.89). For the entire n=99 samples, relative agreement using a cut-off of 20 ng/mL or greater was 91%, and the relative agreement for values less than 20 ng/mL was 98%, with an overall agreement of 94%.
8. Clinical Study
Patients (n=100) with a diagnosis of chronic renal insufficiency were evaluated with the NA 25-OH-D. Using a cutoff of 20 ng/mL, the results demonstrate the assay recognizes vitamin D deficiency and vitamin D insufficiency, consistent with biochemical measures of disordered calcium mineral ion metabolism. As renal failure becomes progressive worse, the frequency of low 25-0H-D levels increases as do biochemical measures of worsening indices of calcium mineral ion metabolism.
{1}------------------------------------------------
9. Similarities:
- Intended use for each assay is identical. .
- Both assays use 25-OH-D3 in their standards, and both report values using the same units: ● ng/mL.
- Both assay use the competitive ligand binding technique. .
- Both assays are capable of using serum, EDTA and heparinized plasma as samples. .
10. Differences:
The following differences pertain to differences in immunoassay technology and do not affect the intended uses of the NA 25-OH-D assay.
| Feature | Nichols 25-OH-D | DiaSorin 25-OH-D |
|---|---|---|
| Sample Size: | 20 uL serum or plasma | 50 ul serum or plasma |
| Solid Phase/PrecipitatingComplex: | 25-OH-D3 magnetic particles | Donkey anti-goat + normal goatserum + PEG precipitatingcomplex. |
| Label: | Acridinium-ester labeled Anti-DBP | $^{125}I$ analog o f 25-OH-D3 |
| Binder/Antibody: | Human vitamin D binding protein | Goat anti-25-OH-D |
| Technology | Automated, hands free set-upNo extraction is required. | Manual procedureSeparate extraction is required. |
| Incubation steps and temperature: | 21 minutes @ 37°C (25-OH-Ddisplacement)+ 21 minutes @37°C (assay incubation). | 90 minutes @ 20-25°C + 20minutes @ 20-25°C + 20 minutescentrifugation. |
| Reportable Range | 7-120 ng/mL | 5.0-100 ng/mL |
11. Comparison of Performance Characteristics
| Feature | Nichols 25-OH-D | DiaSorin 25-OH-D |
|---|---|---|
| Sensitivity | Analytical: 4 ng/mLFunctional: 7 ng/mL | Analytical: ≤ 1.5 ng/mLFunctional: 2.5 ng/mL (optional std.) |
| Within-Run Precision (%CV) | 3.0-4.5% | 8.6-12.5% |
| Total Precision (%CV) | 6.4-14.5% | 8.2-11.0% |
| Recovery | 90-99% | 92-119% |
| Linearity | 80-109% | 96-110% |
| Specificity @ 50% B/Bo | Vitamin D2 = 1.6%Vitamin D3 = 1.2%25-OH-D2 = 100%25-OH-D3 = 100%24,25(OH)2D3 = 100%25-26-OH2D3 = 39%1,25(OH)2D3 = 1.1% | Vitamin D2 = 0.8%Vitamin D3 = 0.8%25-OH-D2 = 100%25-OH-D3 = 100%24,25(OH)2D3 = 100%25-26-OH2D3 = 100%1,25(OH)2D3 = 11.0% |
Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage 25-Hydroxyvitamin D for the intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage 25-OH-D assay is substantially equivalent to the predicate method.
{2}------------------------------------------------
10.5 Comparison to a Predicate Device
Method comparison was made against the DiaSorin 25-Hydroxyvitamin D 125RIA kit. Both the predicate device and the subject device were performed exactly as described by their respective manufacturer's directional inserts. The NCCLS Method Comparison (EP9A) procedures were followed. There were n=111 total samples assayed, each in duplicate. The samples were assayed over 3 days in 3 different runs, and guality control samples for each run were within their respective ranges. Of the 111 paired samples, 80 were within the reportable ranges of each method and demonstrated acceptable levels of imprecision. We used 4 standard deviations to delete outliers for reasons of imprecision. Twelve samples demonstrated unacceptable levels of imprecision (>4 sd) and were deleted. Nineteen samples were below the reportable range (<7 ng/mL) with the subject device, and of these, 4 were below the reportable range with the DiaSorin assay (<5 ng/mL). Tabulated data showing the above three groups are located in Appendix 6.
Method comparison statistical analysis was performed with the 80 samples that demonstrated acceptable levels of imprecision. The 80 samples with good precision and the 19 samples that were below the reportable ranges were combined to determine overall concordance using McNemars test. Below is a chart summarizing the levels of imprecision observed in the 80 samples with acceptable levels of imprecision. These data demonstrate that the Nichols Advantage 25-OH-D assay has better within-run precision.
| N=80 paired samples | Nichols Advantage25-OH-D | DiaSorin 25-OH-D |
|---|---|---|
| Ave. CV | 4.7% | 10.6% |
| Median CV | 3.3% | 9.1% |
| Minimum CV | 0.1% | 0% |
| Maximum CV | 25.4% | 35.0% |
NCCLS method comparison analysis was performed on the 80 paired samples. The range of results, the Deming method comparison analysis, the Passing and Bablok method comparison, the Pearson correlation, and the NCCLS bias
41
{3}------------------------------------------------
analysis are summarized in the chart below. These data, and a scatterplot of the entire method comparison are located in Appendix 6.
| Nichols Advantage | DiaSorin 25-OH-D (X) | |
|---|---|---|
| 25-OH-D (Y) | ||
| Range | 7.0-69.5 ng/mL | 5.9-88.8 ng/mL |
| Deming MethodComparison: | Y=0.99(X) + 0.795% confidence slope: 0.85 to 1.1495% confidence intercept: -3.8 to 5.2 | |
| Passing and Bablok MethodComparison: | Y=1.1(X) – 0.695% confidence slope: 0.94 to 1.2795% confidence intercept: -4.6 to 2.1 | |
| Pearson correlation | R=0.8495% confidence: 0.76 to 0.89 | |
| Bias | Ave. bias: 0.6 ng/mL95% confidence of ave. bias: -1.4 to 2.5 ng/mL95% confidence of agreement:lower limit: -16.5 ng/mL (-19.7 to -13.2)upper limit: 17.6 ng/mL (14.4 to 20.9) |
Either the Passing and Bablok analysis or the Deming analysis could have been used for describing the method comparison. Because the Passing and Bablok analysis is not dependent upon a constant level of imprecision for the two methods, we think this analysis accurately reflects the comparison between the two methods. The average bias was small, only +0.6 ng/mL, but the upper and lower limits of the bias was large (-16.5 ng/mL to 17.6 ng/mL). The large bias we observed could be due to several reasons. The bias could have been influenced by the larger imprecision we observed with the DiaSorin, and because the crossreactivity of each assay is slightly different for vitamin D sterols. The issue of crossreactivity differences and differences in technology were previously discussed in the Crossreactivity section of this 510k.
Pearson correlation was not ideal because the range of observed results could have been higher. Several high samples were deleted due to poor imprecision obtained using the DiaSorin assay. Here are two examples:
-
- Nichols: 101.1, 98.1 vs. DiaSorin: 44.3, 70.8
-
- Nichols: 103.8, 100.9 vs. DiaSorin: 89.9, 47.1
We think the Pearson's correlation coefficient would have been higher if those samples were included in the analysis, since the range of results would be
{4}------------------------------------------------
higher. Obtaining samples with high 25-OH-D levels is difficult because levels approaching 100 ng/mL or higher only come from individuals who are ingesting large quantities of vitamin D or are taking pharmacologic doses of vitamin D. Our method comparison study shows good agreement between methods across the reportable ranges, but potentially with large bias for values above approximately 20 ng/mL. The concordance chart below further illustrates this bias.
Concordance chart showing number of sample results falling within the specified ranges. The concordance chart include the 19 samples below the reportable range, and the 80 samples used in the method comparisons.
| Adv.25-OH-D(ng/mL) | 0-10 | 10.1-20 | 20.1-30 | 30.1-40 | 40.1-50 | 50.1-60 | 60.1-80 | ≥80.1 |
|---|---|---|---|---|---|---|---|---|
| 0-10 | 18 | 7 | ||||||
| 10.1-20 | 4 | 16 | 4 | 1 | ||||
| 20.1-30 | 13 | 1 | ||||||
| 30.1-40 | 11 | 5 | 5 | 1 | 1 | |||
| 40.1-50 | 1 | 2 | 3 | 1 | ||||
| 50.1-60 | 1 | 1 | ||||||
| 60.1-80 | 1 | 1 | ||||||
| >80.1 |
DiaSorin 25-OH-D (no/ml )
Using a cutoff of 20 ng/mL or higher, the relative agreement between methods were calculated.
Relative agreement at 20 ng/mL or less: [45/(45+1)] x 100 = 97.8% Relative agreement at 20 ng/mL and higher: [48/(5+48)] x 100 = 90.6% Overall agreement using 20 ng/mL as the cutoff: [45+48/99] x 100 = 93.9%
Using a cutoff of 20 ng/mL as the lower limit for vitamin D sufficiency, the subject device demonstrates a relative agreement of 90.6% with the DiaSorin assay at 20 ng/mL and higher. This demonstrates that the subject device is substantially equivalent to the DiaSorin kit in detecting absence of low 25-OH-D levels for determining vitamin D sufficiency. For values below 20 ng/mL, the subject device demonstrates a relative agreement of 97.8% with the DiaSorin kit in identifying low 25-OH-D levels. The overall agreement was 93.9%.
In conclusion, these results in addition to the previous clinical study that evaluates levels of 25-OH-D in patients who are at great risk for vitamin D insufficiency and vitamin D deficiency demonstrate that this device is safe and effective for its 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 or bird symbol, composed of three curved lines, representing the department's mission. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 92001
Mr. Jimmy Wong Manager. Clinical and Technical Affairs Nichols institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675
Re: K012367
Trade/Device Name: Nichols Advantage 25-Hydroxyvitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: JIT, MRG Regulatory Class: Class I, reserved Product Code: JJX Dated: September 26, 2001 Received: September 27, 2001
Dear Mr. Wong:
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 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); 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.
{6}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and 1 IT you desire specific acrice for your dotic devices), please contact the Office of Compliance at additionally 607.10 for in Nue and successions on the promotion and advertising of your device, (301) 594-4568. Additionally, for quest (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Constant Constitution w.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
2.0 Indications For Use Statement
| INDICATIONS FOR USE STATEMENT |
|---|
| ------------------------------- |
| 510(k) Number: | K012367 |
|---|---|
| ---------------- | --------- |
Nichols Advantage 25-Hydroxyvitamin D Device Name:
Indications for Use Statement: The Nichols Advantage® 25-Hydroxyvitamin D assay is for use only on the Nichols Advantage® Specialty System. The Nichols Advantage 25-Hydroxyvitamin D assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used as an aid in the assessment of vitamin D sufficiency in an adult population. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or 510(k) Number
Over -The-Counter Use (Optional Format 1-2-96)
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.