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510(k) Data Aggregation
(24 days)
Human IgM Kit for use on SPAPlus
This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
The SPAPlus IgM Kit comprises the following reagents:
Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
The provided document (K191465 - Human IgM Kit for use on SPAPlus Special 510(k) Submission Summary) describes the analytical and performance characteristics of a quantitative in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the questions regarding acceptance criteria for AI/ML performance, ground truth establishment by experts, MRMC studies, and training/test set details are not applicable.
This submission is for a modification to an existing device (Human IgM Kit for Use on SPAPlus, K082129), specifically changing the source of the detection antibody from sheep to goat and altering the antibody resting buffer. The primary goal of the studies presented is to demonstrate that these changes do not adversely affect the device's performance compared to the original cleared device and that the new kit is substantially equivalent.
Here's an attempt to answer the questions based on the available information, noting when a question is not applicable to this type of device:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Since this is a chemistry assay device, the "acceptance criteria" are more about demonstrating comparable performance to the predicate device and meeting established analytical performance standards for in vitro diagnostics rather than an AI/ML output metric like accuracy or AUC.
| Performance Characteristic | Acceptance Criteria / Goal | Reported Device Performance |
|---|---|---|
| Precision | Comparable to the predicate device (K082129) and consistent with established CLSI guidelines (EP5-A3). | Repeatability and Within Laboratory: |
| Level 1 (0.344 mg/L): Total CV% = 6.1 | ||
| Level 2 (2.949 mg/L): Total CV% = 4.0 | ||
| Level 3 (5.975 mg/L): Total CV% = 2.9 | ||
| Between Instrument: | ||
| Level 1 (0.340 mg/L): CV% = 2.4 | ||
| Level 2 (2.994 mg/L): CV% = 5.4 | ||
| Level 3 (6.184 mg/L): CV% = 4.8 | ||
| Between Lot: | ||
| Level 1 (0.318 mg/L): CV% = 3.0 | ||
| Level 2 (3.007 mg/L): CV% = 3.0 | ||
| Level 3 (6.236 mg/L): CV% = 4.7 | ||
| Conclusion: No change in performance compared to K082129. | ||
| Linearity/Assay Range | Maintain linearity and reportable range comparable to the predicate (K082129). | Linear regression equation: y = 0.9904x - 0.1583 g/L with an r value of 0.999. |
| Conclusion: Comparable to predicate, linearity claims unchanged. | ||
| Kit Stability | Maintain stability claims (12 months at 4ºC) in accordance with ISO 23640:2015 and CLSI EP25-A. | Accelerated Stability: |
| All parameters (IR, Control Low, Control High, Samples 1, 2, 3) passed acceptance criteria for 365 days stability at 4ºC based on accelerated testing (39-47.3 days at 37ºC). | ||
| Conclusion: Stability claim of 12 months verified. | ||
| Real Time Stability: Ongoing. | ||
| On Board Stability: No difference from original 510(k) submission. | ||
| Detection Limit (LoD/LoQ) | Maintain LoD, LoB, and LoQ claims comparable to the predicate (K082129) and conform to CLSI EP17-A2. | LoQ: Validated as 0.2 g/L (at standard 1/20 dilution) with all samples reporting within 10% allowable CV. |
| LoD: Estimated 0.004 g/L. | ||
| LoB: Estimated 0.001 g/L. | ||
| Conclusion: No change in performance observed after antisera change; claims unchanged. | ||
| Method Comparison | Demonstrate substantial equivalence to the predicate device. | Bland Altman Mean Bias: -2.18% (95% Limits: -16.55% to 12.18%) |
| Passing Bablok: y = 0.964x + 0.008 (Slope 95% CI: 0.947 to 0.986, Intercept 95% CI: -0.008 to 0.028) | ||
| Correlation coefficient: 0.996 (for sample ranges 0.107 - 11.780 g/L for predicate; 0.116 - 11.066 g/L for test device). | ||
| Conclusion: No change in performance compared to K082129. | ||
| Reference Range Transfer | ≤2 out of 20 samples fall outside the established reference interval (0.35 - 2.42 g/L) for US donors. | 19 out of 20 samples were within the reference interval (0.364 to 1.736 g/L). One sample was 0.348 g/L (lower boundary 0.35 g/L). |
| Conclusion: Met acceptance criteria, indicating reference interval can be transferred. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision Studies:
- Repeatability & Within Laboratory: 3 different samples, 80 replicates each (20 working days, 2 runs/day, 2 reps/run).
- Between Instrument: 3 different samples, 24 replicates each (6 working days, 2 instruments/day, 2 reps/instrument).
- Between Lot: 3 different samples, 24 replicates each (6 working days, 2 lots/day, 2 reps/lot).
- Provenance: Not explicitly stated, but likely retrospective lab testing from the manufacturer (The Binding Site Group Ltd. in UK). Dates of testing are implied by "over 20 working days" etc.
- Linearity Study: High and low pools, dilution series, 6 replicates per diluted sample.
- Provenance: Not explicitly stated, likely retrospective lab testing.
- Stability Studies:
- Accelerated Stability: 6 replicates of controls, internal reference, and samples.
- Provenance: Not explicitly stated, likely retrospective lab testing.
- Detection Limit (LoQ) Study: Four samples, two reagent lots.
- Provenance: Not explicitly stated, likely retrospective lab testing.
- Method Comparison Study: 89 serum samples and 44 plasma samples.
- Provenance: Performed "in accordance with pre-submission meeting Q171503." Not explicitly stated, but likely retrospective from clinical laboratories or biobanks.
- Reference Range Transfer Study: 20 samples from "apparently healthy US donors."
- Provenance: Prospective collection from apparently healthy US donors appears to be implied given the mention of "US donors" and the purpose of transferring the reference interval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is an in vitro diagnostic device that measures a quantitative analyte (IgM). "Ground truth" for this type of device is established by the analytical measurement itself, traceable to an international reference material (ERM-DA470k/IFCC). Clinical expert consensus is not a method for establishing the "ground truth" concentration of an analyte in a sample for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or clinical diagnosis, often when human expert variability is a factor. This submission is for a turbidimetric assay, where the "ground truth" is a quantitative measurement traceable to a reference standard.
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
Not applicable. This is not an AI/ML device and does not involve human readers interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "performance" is the analytical performance of the assay itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the quantitative measurement of IgM in this IVD is established by its traceability to a recognized international reference material (ERM-DA470k/IFCC). This standard provides the authoritative value for IgM concentration against which the device's measurements are calibrated and compared.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a "kit" of reagents and controls used on an analyser.
9. How the ground truth for the training set was established
Not applicable (as above, no "training set" in the AI/ML sense). The calibration of the assay (which could be conceptually analogous to "training" a traditional assay) is traceable to ERM-DA470k/IFCC, an international reference material.
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